Safety alert

2017-184

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/440889-fda-advisory-no-2017-184

Fda advisory no. 2017-184 voluntary recall nc trex rx coronary dilatation catheter, with mdr-00260 all are hereby advised by the food and drug administration (fda) about the voluntary recall of the following nc trex rx coronary dilatation catheter with mdr-00260 product code 1012448-06,1012448-08,1012448-12,1012448-20, 1012449-08, 1012449-12, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 101250-15, 101251-12, 101251-15, 1012452-08, 1012452-12, 1012453-12, 1012453-15, 1012453-20 distributed by getz bros. philippines, inc. 5th floor ortigas bldg., ortigas avenue, pasig city: product code: mdr-00260 description: nc trex rx coronary dilatation catheter (2. 75 mm, 3.00 mm, 3.25 mm, 3.50 mm, 3.75 mm & 4.00 mm) product code lot numbers product code         lot numbers                 1012448-06       60414g1 60721g1         1012448-20 60310g1 60421g1 60421g2 60527g1 60716g1 60819g1 60024g2         1012448-08             1012551-25     60208g1 60419g1 60420g1 60603g1 60906g1 61121g1 61121g2     60809g1               1012449-08 60317g1 60318g1 60412g1 60419g1 60502g1 60502g2 60525g1 60705g1 60801g1 60809g1 60826g1 60916g1 61121g1 61121g2         1012448-12                         1012448-12                                  1012449-20                     1012453-20 60225g1 60229g1 60318g1 60318g2 60429g1 60429g2 60607g1   60705g1 60804g1 60818g1 60921g1 60921g2 61108g1 61111g1 61128g1 61128g2 61218g1   60126g1 60223g1 60225g1 60226g1 60323g1 60331g2 60516g1 60519g1 60721g1 60805g1 60824g1 60907g1 61004g1 61116g1 61130g1   60209g1 60226g1 60505g1 60623g1 61122g1       1012449-12                                         1012449-12 60218g1 60303g1 60330g1 60330g2 60406g1 60406g2 60406g3 60406g4 60408g1 60413g1 60413g2 60425g1 60429g1 60511g1 60512g1 60531g1 60607g1 60623g1 60713g1 60721g1 60804g1 60805g1 60809g1 60816g1 60824g1 60926g1 60929g1 61012g1 61019g1 61019g2 61020g1 61115g1 61121g1 61122g1 61123g1 61123g2 61201g1 61208g1 61214g1 61214g2 61216g1 61216g2      1012451-12           1012452-08             1012450-15                             1012451-15   60205g1 60214g1 60502g1 61108g1 61213g1   60810g1 60921g1 61007g1 61216g1   60315g1 61130g1 60718g1 60901g1 60922g1 61128g1 60414g2 60505g1 60331g1 60224g1     60210g1 60224g1 60331g1 60505g1 60408g2 60913g1 60909g2 60828g2 60826g1 60727g1 60701g1 60607g1 60603g1     1012449-25       1012450-06         1012450-08         1012452-12       1012453-12                   1012453-15   60405g1 60412g1 60805g1     60610g1 61101g1   60530g1 60803g1 61014g1 61206g1   50109g1 50316g1 50210g1   60705g1 60810g1 60502g1 60621g1     60301g1 61111g1 61026g1 61121g1 60822g1 60428g1 60819g1 60331g1 60721g1 60909g1 60613g1 60303g1 60617g1 the cited product are being voluntarily recalled by getz bros. philippines, inc. because abbot vascular has initiated a voluntary field action regarding specific lots of the nc trex rx coronary dilatation catheter, nc traveller rx coronary dilatation catheter, and nc tenku rx ptca ballon catheter. production from the identified lots may exhibit difficult in removing the protective ballon sheath which can result in issues with inflating or deflating the ballon. the worldwide frequency of tight sheath removal, inflation and deflation and reported event is 0.12%. potential risks associated with ballon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardiac infarction. in one reported case, failure to deflate the ballon necessitated surgery, leading to multiple post-operative complication and death. distributors, retailers, hospitals that have any of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-184.Pdf.

Safety alert

2018-157

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/505153-fda-advisory-no-2018-157

Fda advisory no. 2018-157 lifting the advisory of sure-guard pregnancy test kit under fda advisory no. 2018-130, subject “public health warning against the purchase and use of the unregistered medical device product sure-guard pregnancy test kit” the food and drug administration (fda) informs the public that the advisory on the medical device product “sure-guard pregnancy test kit” under fda advisory no. 2018-130 dated 06 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the medical device product is registered with certificate of product registration no. ivdr-00229 under company amb hk enterprises, inc. the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.  for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. .   attachments: fda advisory no. 2018-157.Pdf.

Safety alert

2018-297

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/526435-fda-advisory-no-2018-297-voluntary-product-recall-of-the-following-medical-device-products

All concerned healthcare professionals and stablishments are hereby advised by the food and drug administration (fda) regarding the product recall of specific batch of novosyn violet dyed suture with needle with mdr-00091 and safil violet surgical suture with dvr-5893, imported and distributed by b. braun medical supplies inc...   to continue reading, download attachment... attachments: fda advisory no. 2018-297.Pdf.

Safety alert

2017-283

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/468818-fda-advisory-no-2017-283

Fda advisory no. 2017-283  voluntary recall of diamond burr with coarse and extra-coarse grain (pursuant to system) all concerned healthcare professionals are hereby advised by the food and drug administration (fda) regarding the voluntary recall of diamond burr (see photos of the product below) distributed by b. braun medical supplies, inc. diamond burrs are used in spine surgery and cranial neurosurgery in the area of working on hard tissue. the following list of affected articles: gp161r elan 4 1-ring diamond burr coarse d2.0gp162r elan 4 1-ring diamond burr+ coarse d2.0gp163r elan 4 1-ring diamond burr coarse d2,3gp164r elan 4 1-ring diamond burr+ coarse d2,3gp165r elan 4 1-ring diamond burr coarse d3,0gp166r elan 4 1-ring diamond burr+ coarse d3,0gp167r elan 4 1-ring diamond burr++ coarse d3,0gp168r elan 4 1-ring diamond burr coarse d4,0gp169r elan 4 1-ring diamond burr coarse d5,0gp170r elan 4 1-ring diamond burr coarse d6,0gp321r elan 4 2-ring diamond burr coarse d2.3gp322r elan 4 2-ring diamond burr coarse d3.0gp323r elan 4 2-ring diamond burr coarse d4.0gp324r elan 4 2-ring diamond burr coarse d5.0gp325r elan 4 2-ring diamond burr coarse d6.0ge426r hi-line xs diamond burr x-crs.I d4.5mmge426su hi-line xs disp.Diam.Burr x-crs.I d4.5mmge526r hi-line xs diamond burr x-crs.Ii d4.5mmge526su hi-line xs disp.Diam.Burr x-crs.Ii d4.5ge626r hi-line xs diamond burr x-crs.Iii d4.5mmge626su hi-line xs disp.Diam.Burr x-crs.Iii d4.5gp173r elan 4 1-ring diamond burr x-coarse d3,0gp174r elan 4 1-ring diamond burr x-coarse d4,0gp175r elan 4 1-ring diamond burr x-coarse d5,0gp176r elan 4 1-ring diamond burr x-coarse d6,0gp177r elan 4 1-ring diamond burr x-coarse d7,0gp328r elan 4 2-ring diamond burr x-coarse d4.0gp329r elan 4 2-ring diamond burr x-coarse d5.0gp330r elan 4 2-ring diamond burr x-coarse d6.0 the above-stated medical device products are being voluntary recalled by b. braun medical supplies, inc. the use of these tools under some conditions can result in the release of particles from the diamond coating, which may not be discovered by the user. it was observed that during operation particles can break out oneself from the diamond burr fall into the situs. if the particles are not detected after breaking out and thus are not removed from the wound the particles can remain to a certain extent in the patient’s body. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested.     attachments: fda advisory no. 2017-283.Pdf.

Safety alert

2018-160

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/505156-fda-advisory-no-2018-160

Fda advisory no. 2018-160  voluntary recall of the bd vacutainer® plus sst tube with hemogard closure with product registration dvr no. 3713 metro drug inc., the importer/distributor of bd vacutainer® plus sst tube with hemogard closure with the product registration number dvr-3713. has informed the food and drug administration of the voluntary recall of the said product, specifically described as follows: product name bd vacutainer® plus sst tube with hemogard closure specifications 13x75mm x 3.5ml catalog code 367983 lot no. 7135828 and 7125692 intended use for the collection of venous blood packaging/selling unit shelf pack of 100 tubes/case of 10 shelf packs registration no. dvr-3713 product name bd vacutainer® plus sst tube with hemogard closure specification 13x100mm 5.0ml catalog no. 367986 lot no. 7146901 intended use for the collection of venous blood packaging/selling shelf pack of 100 tubes/case of 10 shelf packs registration no. dvr-3713 said items are being voluntarily recalled due to reports of bd has confirmed that a limited number of tubes associated with the above lots of bd portion of the lots bd vacutainer® plus sst tubes which are currently in the market may exhibit stopper creeper-out/pull-out/pop-off, where the stopper dissociates from the tube. an example of stopper creep-out/pull-out/pop-off is demonstrated in figure above. bd has received reports of this issue occurring during collection and processing (including centrifugation, transportation and testing). stopper creep-out/pull-out/ pop –off can result in potential user exposure to blood resulting from an un- stoppered tube, which may result in exposure to blood borne pathogens. lot and ref numbers that are critical in determining the identity of the product for traceability. in the report to the fda , metro drug inc. disclosed that the affected lots were not distributed in the philippine market as per their distribution list record. at any rate, distributors, retailers and hospitals that have any lot of the stated medical device product are instructed to discontinue their further distribution, sale, and use. furthermore, other distributors of said product shall coordinate with the fda for the conduct of product recall. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-160.Pdf.

Safety alert

2017-315

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/475190-fda-advisory-no-2017-315

Fda advisory no. 2017-315 voluntary recall of bd vacutainer k2 edta (k2e) 3.6mg blood collection tube, 13 x 75mm x 2.0ml all concerned healthcare professionals, establishments and the general public are hereby advised by the food and drug administration (fda) regarding the voluntary recall of bd vacutainer k2 edta (k2e) (see photos of the product below) distributed by metro drug, inc. bd vacutainer k2 edta (k2e) 3.6mg blood collection tube is used for the collection of venous blood. product name : bd vacutainer k2 edta (k2e) 3.6mg blood collection tubespecifications : 13 x 75mm x 2.0mlcatalog code : 367841lot. no. : 6279849intended use : for the collection of venous bloodpackaging/selling unit : shelf pack of 100 tubes/case of 10 shelf packsregistration no. : dvr – 3711 bd vacutainer k2 edta (k2e) 3.6mg blood collection tube(13 x 75mm x 2.0ml)recall catalog (ref) / lot identification sample    the above-stated medical device products are being voluntary recalled by becton dickinson and company (bd). bd has confirmed that a limited portion of the lot was manufactured with less than the required amount of [email protected] additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-315.Pdf.

Safety alert

2018-045

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488564-fda-advisory-no-2018-045

Fda advisory no. 2018-045  voluntary product recall of guider softip guiding catheter all concerned healthcare professionals and establishments are hereby advised by the food and drug administration (fda) regarding the voluntary product recall of specific lots of guider softip guiding catheter with dvr no. 4230 (see photos of the product below), distributed and imported by partners’ choicemed, inc. description lot no. guider/ 40 deg xf /7fr/ 9cm   19793264 18056772 20013730 20601623 17987235 17997088 19791829 20471803 18056695 19787277 20144784 20601934 18116710 20471804 description lot no. guider/ 40 xf /8f/ 90cm   19157528 19159673 partners’ choicemed, inc. received a notice of product recall from stryker neurovascular, in coordination with boston scientific the manufacturer of the above-mentioned medical device product. stryker neurovascular has become aware that the above-mentioned lots of guider 7f and 8f product may be at risk of degrading within its shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017. patients previously treated with the impacted devices are not at risk. for potential patients, the reported issue can cause the embolization of degraded polymer fragments into the neurovasculature which can cause stroke. there have been no reports of catheter degradation or injury. all concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-045.Pdf.

Safety alert

2017-206

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/447571-fda-advisory-no-2017-206

Fda advisory no. 2017-206 public health warning against the purchase and use of the unregistered medical device product “fresenius optiflux f180nr dialyzer” the food and drug administration (fda) advises the public against the purchase and use of the unregistered medical device product fresenius optiflux f180nr dialyzer: fda post-marketing surveillance (pms) activities have verified that the abovementioned dialyzer has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited. accordingly, since this unregistered dialyzer has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public. in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against dialyzer that might not be duly registered with fda. always check if a dialyzer has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at ww2.Fda.Gov.Ph. all concerned establishments and/or entities are warned not to distribute the above-identified violative dialyzer until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. , or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-206.Pdf.

Safety alert

2018-240

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525285-fda-advisory-no-2018-240

Fda advisory no. 2018-240 termination of the voluntary recall of  av-set b dt inf-e blood tubing system with dvr no. 8574 (article no. ap16641) the food and drug administration (fda) informs the public that fresenius medical care philippines, inc., marketing authorization holder (mah), has reported that it has completed the recall and removal of av-set b dt inf-e blood tubing system (see figures 1 and 2) with dvr no. 8574 (article no. ap16641) from the philippine market. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-240.Pdf.

Safety alert

2018-213

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/514738-fda-advisory-no-2018-213

Fda advisory no. 2018-213 voluntary recall of stay safe disinfection cap with batch number z1z04300 the food and drug administration (fda) informs the public and all concerned healthcare professionals that fresenius medical care philippines, inc. has voluntarily recalled the stay safe disinfection cap with batch number z1z04300. it has been discovered that this batch number was distributed without local label sticker. the application stickers for the mentioned batch was missed by their sub-distributor. appropriate corrective and preventive actions will be instituted to prevent recurrence.  as a mitigating measure they will provide replacement of the said medical device product to the affected customers to ensure continuity of care. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-213.Pdf.

Safety alert

2019-007

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/549847-fda-advisory-no-2019-007

The food and drug administration (fda) informs the public that fresenius medical care phils., marketing authorization holder (mah), has reported that it has completed the recall of stay safe disinfection cap with batch number z1z04300 from the philippines market. dissemination of the information to all concerned is requested.   attachments: fda advisory no. 2019-007.Pdf.

Safety alert

2018-162

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/505158-fda-advisory-no-2018-162

Fda advisory no. 2018-162 product advisory notice of halyard health inc.   the food and drug administration (fda) informs the public and all healthcare concerned professionals that halyard health, incorporated manufacturer of halyard closed suction kits with connector and panamed philippines inc. as their distributor has voluntarily submit a product advisory notice for the products with dvr number of 7454 and 7452. panamed philippines inc. inform the fda that halyard health inc. received reports that certain flex connectors supplied with halyard closed suction kits with flex connectors may become loose or disconnect before use or during use. risk to health:  if disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.  although the reported risk of occurrence is low, this advisory is intended to inform the general public and all the healthcare professionals about this potential issue and provide steps to help prevent this issue from occurring during use.  specific instruction before use: please ensure adequate connection of the flex connector to swivel connector before use. before using the flex connector evaluate its connection to the swivel connector of the closed suction adapter to ensure adequate connection. evaluation of the connection can be accomplished by pushing the flex connector onto the swivel connector. an adequate connection (fig. 1) is defined when a tight fit is achieved on the swivel with the flex connector advanced approximately three-quarters over the swivel, so a gap remains visible. an inadequate connection (fig. 2) is defined when the bottom of the flex connector advances all the way to the end of the swivel connector, where a gap is no longer visible. if an inadequate connection is observed, the flex connector may be replaced with a new, sterile flex connector and the system connection should be re-evaluated. if use of a flex connector with ventilator circuit is optional, the closed suction swivel connector can be connected directly to the ventilator circuit. specific instruction during use: if a disconnection between the flex connector and swivel connector is observed during use, replace the flex connector with a new, sterile flex connector and ensure adequate connection as described in this notice. distributors, retailers, hospitals and all healthcare professionals / users are advised to coordinate with panamed philippines inc. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. attachments: fda advisory no. 2018-162.Pdf.

Safety alert

2013-048

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/119167-fda-advisory-no-2013-048

Fda advisory no. 2013-048 quality hold on soluset tm 100 burette iv (intravenous) set imported by hospira philippines, inc.  in the interest of public health and safety, the food and drug administration (fda) and hospira philippines, inc. will jointly undertake a quality hold of the product solusettm 100 burette iv (intravenous ) set, with its clamp and secure lock.  hospira philippines, inc., as part of their due diligence responsibility, will do a quality check on solusettm 100 burette iv (intravenous) set found in the market, specifically those with batch numbers 1707456 and 1707856. solusettm 100 burette iv (intravenous) set is manufactured by hospira de costa rica ltd., costa rica and registered in the philippines with fda registration no. dvr-2362. all consumers and health professionals are advised not to use the said batches of solusettm 100 burette iv (intravenous) set until such time that the fda and hospira philippines, inc. shall have issued an advisory that the quality hold has been lifted.  likewise, distributors and drug outlets are ordered to remove the stocks from their shelves and hold the said stocks until the fda and hospira philippines, inc. shall have conducted the quality check.  for inquiries, email us at this email address is being protected from spambots. you need javascript enabled to view it. . for strict compliance of all concerned. attachments: fa2013-048 - quality hold on soluset 100 burette iv set imported by hospira phil.

Safety alert

2014-046

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/164059-fda-advisory-no-2014-046

Fda advisory no. 2014-046 lifting of the quality hold in soluset 100 burette intravenous iv set imported by hospira philippines inc on 04 november 2013, fda advisory no. 2013-048; quality hold on soluset 100 burette iv (intravenous) set imported by hospira philippines inc was issued to conduct quality check. testing was conducted by the laboratory unit of food and drug administration on 09 december 2013 on 18 sets of soluset burette intravenous (iv) set batch number 170785g. the test has a satisfactory result and passed the sterility test.  a seperate investigation was conducted by hospira philippines, on all the remaining stocks of soluset tm burette intravenous (iv) set. historical complaints search, review of the batch record, evaluation of the inspection results of visual checking and physical evaluation of the two lot numbers invloves were conducted by the company. this resulted to no discrepancies that may have contributed to the complaint are improper use of hairnet and gowning during the coiling, packaging or sealing process. the qa/production management personnel of hospira were notified. proper gowning and wearing of hairnet was implemented in the clean room to mitigate this kind of problem from occurring. in this regard, the quality hold on solucet tm burette intravenous (iv) set imported by hospira philippines inc. with batch number 170145g and 170785g is hereby lifted effective immediately. hospira philippines inc can now sell the products       attachments: fa2014-046.Pdf.

Safety alert

2018-237

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525279-fda-advisory-no-2018-237

Fda advisory no. 2018-237 lifting the advisory of indoplas infrared ear thermometer under fda advisory no. 2018-120 re: “public health warning against the purchase and use of the unregistered medical device product (indoplas infrared ear thermometer)” the food and drug administration (fda) informs the public that the advisory on the medical device product “indoplas infrared ear thermometer” under fda advisory no. 2018-120 dated 02 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the above-mentioned medical device product is registered with certificate of product registration no. mdr-06882 valid until 29 june 2019 under company indoplas philippines, inc. the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations. for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. . attachments: fda advisory no. 2018-237.Pdf.

Safety alert

2014-032

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/153576-fda-advisory-2014-032

Fda advisory no. 2014-032 false, deceptive and misleading claims and strategies to promote "izumi 5p antioxidant alkaline water ionizer" the food and drug administration (fda) issued advisory no. 2014-010 dated 27 january 2014 warning consumers against false, deceptive and misleading claims regarding alkaline water and or water purification devices. despite issuance of the aforesaid advisory, the fda has monitored the newspaper advertisement of izumi 5p antioxidant alkaline water ionizer published in the philippine daily inquirer dated 31 march 2014 page a-25 entitled "the secret to a healthier, longer life" and philippine star, 4 april 2014 issue, page 13, allegedly comparing the benefits of drinking alkaline water produced by izumi ionizer, to that of a japanese guinness book of records holder oldest documented living person who was discovered to be drinking water from a preserved water source. the fda also monitored izumi website at http://izumilifestyle.Com and found that it is being used to advertise deceitful health and therapeutic claims, among others: a quick search at the fda website reveals that izumi alkaline water ionizer is not registered with the fda-center for device regulation, radiation health, and research. it is therefore a direct violation of ra 9711. otherwise known as the fda act of 2009, to sell or offer for sale or advertise the said purification device product that allegedly produce water known as "alkaline water" and make therapeutic claims unless covered by a certificate of product registration (cpr) and the importer/distributor is licensed by the fda. drinking alkaline water or ionized water does not change the blood ph level or remove every known chronic disease condition. there are no scientific and clinical studies that would support or back-up its health and therapeutic claims. consumers are, thus, strongly advised not to fall prey to these type of misleading, deceptive advertisements and are forewarned against buying and using unregistered izumi alkaline water ionizer since it is not an fda-approved water purification device. all consumers are advised to be more vigilant and critical about on-line and printed advertisements so as not to fall prey to the marketing schemes of unscrupulous companies. the importer and advertiser of izumi 5p antioxidant water ionizer is directed to immediately stop from further importing, advertising and selling the subject unregistered water purification device unless registered with the fda. for more information and inquiries, kindly email us at this email address is being protected from spambots. you need javascript enabled to view it. .  attachments: fa2014-032 - false deceptive and misleading claims and strategies to promote izu.

Safety alert

2018-046

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488565-fda-advisory-no-2018-046

Fda advisory no. 2018-046 public health warning against the use of unregistered medical device (mersilk black braided silk suture n536) the food and drug administration (fda) hereby advises all concerned healthcare professionals, establishments and general consuming public against the purchase and use of mersilk black braided silk suture n536 manufactured by johnson & johnson pakistan pvt limited, korangi industrial area, karachi whose picture appears below: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded are prohibited. the abovementioned product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety. furthermore, fda, in coordination with the market authorization holder (mah), johnson & johnson philippines, inc., has verified that the above-stated medical device product is counterfeit. in this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with the fda. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said medical device product. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that the product is not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and development division - center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-046.Pdf.

Safety alert

2018-207

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/514565-fda-advisory-no-2018-207

Fda advisory no. 2018-207  voluntary recall of harmonic ace® laparoscopic 5mm diameter shears + adaptive tissue technology (specific lots only for codes har23 and har36) the food and drug administration (fda) informs the public and all concerned healthcare professionals that johnson & johnson philippines, inc. has voluntarily recalled specific lots of harmonic ace® laparoscopic 5mm diameter shears + adaptive tissue technology (specific lots only for codes har23 and har36), with the following impacted lot numbers: product name product code product lots harmonic ace®+ shears with adaptive tissue technology (23cm length) har23 p9125c p93w8a p94a93 p94h9v p93t5j p93y4a p94a94 p94j28 p93t5k p93z4x p94c8r   p93v06 p93z96 p94e6u   p93w0a p9400f p94g1w   p93w4y p9409v p94h32   harmonic ace®+ shears with adaptive tissue technology (36cm length) har36 n93923 p93m6p p93u5n p94c47 n9392k p93m6t p93u90 p94c5r p9129w p93n00 p93u91 p94c8t p91394 p93n01 p93v02 p94d0m p9139n p93n3x p93v03 p94d0p p9144r p93n3y p93v0v p94d3j p9148k p93n5a p93v57 p94d3k p9149j p93n7h p93v5t p94d5g p9168k p93p09 p93w9r p94d9k p9173r p93p26 p93w9x p94e1z p9174k p93p2e p93x2g p94e20 p91795 p93p7g p93x2w p94e3z p91c51 p93p7h p93x2x p94e8w p91c83 p93r0z p93x85 p94f1m p91f2x p93r10 p93x98 p94f3a p91k69 p93r4f p93y47 p94f5t p91l0h p93r4g p93y48 p94f6c p91l1y p93r56 p93y8x p94f7l p91l6e p93r57 p93z4t p94g1h p91l6j p93r6u p93z5x p94g1j p9396a p93r6v p93z95 p94h0k p9396c p93t0x p94015 p94h31 p9399t p93t20 p9414t p94h4v p93a1l p93t26 p94a5k p94h8j p93l47 p93t9l p94a6a   p93l76 p93u0p p94c10   p93m5y p93u17 p94c11   ethicon endo-surgery, llc (“ethicon”), the manufacturer of the above-mentioned products confirmed that some devices contained in theses lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. based on their medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.  for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. attachments: fda advisory no. 2018-207.Pdf.

Safety alert

2017-237

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/454253-fda-advisory-no-2017-237

Fda advisory no. 2017-237 voluntary prodcuct recall of physiomesh composite mesh (mdr-00270) the food and drug administration informs the public that johnson and johnson (phils.) inc., the marketing authorization holder (mah), has voluntarily recalled, removed and destroyed ethicon physiomesh flexible composite mesh – mdr-00270 (for laparoscopic use) from the philippine market. the mah conducted these activities at the request of the ethicon medical safety team after a review of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb). based on the data, there are higher revision rates between physiomesh flexible composite and other meshes in the registries after laparoscopic ventral hernia repair due to a multifactorial issue. consequently, this discrepancy of ethicon physiomesh composite mesh product line has not been fully characterized. thus, a worldwide device removal has been conducted and it is communicated to the u.S. food and drug administration (us fda). in coordination with the fda philippines, the recall, removal and destruction of the medical device has been completed. the summary of the affected batch of products recalled and destroyed are as follows:    product code batch number phy1015v hk8dgkb0 jd8dctb0 jd8dklb0 jd8gdbb0 jk8cclc0 jk8dsmc0 jl8grwd0 jm8gpzd0 kb8bbjd0 phy1515q ee8khza0   hl8dzhb0   hl8hklb0   hp8bjzb0   jd8gdcb0   je8bcxb0   jj8dtxc0   jk8bktc0   jk8ckzc0   jm8cqdd0   ka8hdqd0 phy1520r hl8dtwb0   jd8crjb0   jd8dxhb0   je8brxb0   jm8czzd0 phy1520v eb8hctao   hp8dbkb0   jk8hcc0 phy2025v jb8bbxb0   jb8ddgb0   jb8drgb0   jk8bsxc0   jl8bmhd0   jp8bmzd0   ka8ggkd0 phy2030r hm8dqwb0   hm8gclb0   hp8cjbbo dissemination of the above information to all concerned is requested. attachments: fda advisory no. 2017-237.Pdf.

Safety alert

2017-084

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/413421-fda-advisory-no-2017-084

Fda advisory no. 2017-084 health warning on using covidien valleyab laparoscopic handset (four-function) with product code e2750 all are hereby advised by the food and drug administration (fda) about the lots of the following laparoscopic handsets with product code e2750 distributed by medtronic philippines inc. 32nd street bonifacio global city, fort bonifacio taguig city: product code description lot numbers e2750 valleylab laparoscopic handsets four-function 52990142x 53250061x 53610059x 60240065x 61220095x 52990144x 53250063x 53610061x 60520098x 61220098x 52990147x 53250065x 60240055x 60520104x 61300164x 52990151x 53610053x 60240059x 60870064x 61540145x 53250057x 53610055x 60240061x 61220093x 61540150x the cited product are being voluntarily recalled by medtronic philippines inc. because of the customer reports from its main manufacturer in other country on potential defect/malfunction of the device. in the report, the handset continues to operate upon release of the activation button. if it does not deactivate after release of activation button, it presents safety risk and possible health consequences like damage to the internal tissues. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-084.Pdf.

Safety alert

2018-307

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/526276-voluntary-recall-of-monoclonal-mouse-anti-pneumocystis-jiroveci-clone-3f6-with-product-code-m0778

The food and drug administration (fda) informs the public and all concerned healthcare professionals that mmj biosystem philippines (mmj), inc. has voluntarily recalled the monoclonal mouse, anti-pneumocystis jiroveci, clone 3f6 with product code m0778 with the following lot numbers: 20010445 20030858 20042555 according to mmj, the primary label of the affected vial was mislabeled with an incorrect concentration. for the product code m0778 the concentration was written to be 30 mg/l when the correct concentration is 75 mg/l. mmj further claims that ⁓2.5-fold higher concentration in the vial will have no consequence on the quality of m0778 and the products are expected to perform as usual. lastly mmj claims that if diluted according to the label, the higher concentration will result in stronger signals than expected and may lead to increased background staining and/or false positive staining. positive and negative run controls would detect any problems with staining in this case. in view of the foregoing, distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-307.Pdf.

Safety alert

2017-086

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/420134-fda-advisory-no-2017-086-public-health-warning-against-misuse-of-wariactiv-vapo-coolant-anesthesia-aerosol-spray-ethyl-chloride

Fda advisory no. 2017-086 public health warning against misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride the food and drug administration (fda) advises the public against the misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride (please see picture below). the said product is a registered medical device and was approved as local skin anesthesia. however, the fda received reports that the product is being indiscriminately used by some individuals. the product is being misused by inhaling it to feel “high” or happy. the abuse and misuse of the product’s active ingredient, ethyl chloride, could lead to the following adverse effects: acute (short-term) inhalation exposure to high levels of ethyl chloride in humans has resulted in temporary feelings of drunkenness, dizziness, lack of muscle coordination and unconsciousness.* chronic (long-term) effects include ataxia (uncoordinated movements), tremors, speech difficulties, slowed reflexes, involuntary eye movement, and hallucinations, and liver effects were reported in individuals who purposely inhaled very high concentrations of ethyl chloride for a few months.* sudden sniffing death syndrome**                                                               in the interest of protecting public health and safety from adverse health effects brought about by the abuse and misuse of the product, the public is hereby advised to use the product only in accordance with its approved use. likewise, advertisement of the product in all forms of media other than its approved use is prohibited. retailers are also advised to avoid indiscriminate selling of the product to customers. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. references: 1. united states environmental protection agency website*                          (https://www.Epa.Gov/sites/production/files/2016-09/documents/ethyl-chloride.Pdf)                   2. dr. lynn crisanta r. panganiban, professor, department of pharmacology & toxicology, up college of medicine/consultant, national poison management & control center, up college of medicine – philippine general hospital** attachments: fda advisory no. 2017-086.Pdf.

Safety alert

2017-138

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/433132-fda-advisory-no-2017-138

Fda advisory no. 2017-138 public health warning against the purchase and use of medical devices (condoms) that are unregistered and with expired certificate of product registration (cpr) the food and drug administration (fda) advises the public against the purchase and use of the following medical device products: post-marketing surveillance activities conducted by the fda have verified that playsafe condom easy pack long love + ribbed (see figure 1), playsafe condom extrasafe (see figure 2) and feel condom vibra (see figure 3) have not gone through the registration process of the agency and have not been issued with certificate of product registration (cpr). furthermore, it was found out that the cprs of playsafe condom fix-tex 002 (see figure 4), playsafe condom fix-tex long shock (see figure 5) and feel condom 4 in 1 (see figure 6) are already expired. pursuant to the provisions of  republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited. since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued.  all local government units (lgus) and law enforcement agenies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested.   attachments: fda advisory no. 2017-138.Pdf.

Safety alert

2017-183

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/440485-fda-advisory-no-2017-183

Fda advisory no. 2017-183 public health warning against the use of unregistered medical device products “iodent denture cleanser and iodent denture cleansers overnight whitening” the food and drug administration (fda) advises the public against the use of the unregistered medical device products iodent denture cleanser (20 tablets) and iodent denture cleansers overnight whitening (18 tablets): post-marketing surveillance activities conducted by the fda have verified that the abovementioned medical device products has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration. pursuant to the provisions of republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from fda is prohibited. the abovementioned products did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding certificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued. all local gocvernemnt units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and development division - center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-183.Pdf.

Safety alert

2017-185

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/443185-fda-advisory-no-2017-185

Fda advisory no. 2017-185 public health warning against the purchase and use of medical device (clinical thermometer included in playtex baby healthcare kit) that are unregistered. the food and drug administration (fda) advises the public against the purchase and use of unregistered medical device  - clinical thermometer included in playtex baby healthcare kit. post-marketing surveillance activities conducted by the fda have verified that playtex baby 6pc, healthcare kit (see figure 1 and 2) have not gone through the registration process of the agency and have not been issued with certificate of product registration (cpr). pursuant to the provisions of  republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization are prohibited. since the abovementioned products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued.  all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-185.Pdf.