Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: mercury medical t-piece circuit
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning t-piece circuit, manufactured by mercury medical. product affected was shipped after 18 january 2012. the affected part numbers and the corresponding lot numbers are:
t-piece neonatal circuit kit, disposable
part number: m1091316vs; lot number: 14049 and greater
part number: m1091335vs; lot number: 14043 and greater
part number: m1091365vs; lot number: 14051 and greater
neo-tee resuscitator
part number: 10-50805; lot number: 1426550805 and greater
part number: 10-50809; lot number: 1227550811 and greater
part number: 10-50811; lot number: 1227850809 and greater
t-piece resuscitator circuit
part number: 10-50900; lot number: 1402050900 and greater
part number: 10-50901; lot number: 1427650901 and greater
part number: 10-50902; lot number: 1324850902 and greater
the t-piece circuit is a component used in conjunction with various t-piece resuscitation devices. according to the safety alert, there is a potential that a silicone mask with a 15 mm male port is being able to be forcibly inserted into the protective cap covering the opening of the t-piece circuit. incorrect use of the product in this way will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
the manufacturer advises affected users to immediately notify all personnel subject to using these devices to remove the protective cap before connecting a mask. besides, the manufacturer is in process to physically eliminate the potential for this erroneous use. the instructions for use are also being updated to warn users to remove the cap before use.
for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 october 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: magellan diagnostics leadcare testing systems
the united states food and drug administration (fda) has issued a medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics.
the fda is warning facilities such as laboratories or health clinics that magellan diagnostics’ leadcare testing systems may underestimate blood lead levels (blls) and give inaccurate results when processing venous blood samples. the fda is providing recommendations to help mitigate the risk of inaccurate test results to assure that patients receive accurate information regarding potential lead exposure. the fda is also strongly urging parents and at-risk adults to speak with their health care provider about the u.S. centers for disease control’s (cdc) recommendations on re-testing. the cdc recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.
the fda recommends laboratories and health care professionals take the following actions:
discontinue using magellan’s’ leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples.
report any adverse events to the fda and to magellan diagnostics.
if laboratories or health care professionals are concerned about using the leadcare test systems, the alternative options are mass spectrometry or atomic absorption methods. these are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
this safety communication replaces all previous communication from magellan diagnostics on their leadcare lead testing systems including magellan’s most recent field safety correction notification dated april 28, 2017.
for details, please refer to the fda websites:
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm
https://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm558733.Htm
https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm558769.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 may 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: magellan diagnostics leadcare testing systems (update)
the united states food and drug administration (fda) has issued a statement on findings from ongoing investigation into lead testing issues and an updated medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics.
the fda has conducted investigations with magellan diagnostics as well as becton dickinson (bd), the manufacturer of blood sample collection tubes used alongside with the lead tests, to determine the cause of the inaccurate lead test results from the leadcare testing systems.
the fda concluded that there was a significant chance of false results with magellan’s leadcare tests when used with whole blood collected from the vein and stored in certain bd tubes. upon further investigations, bd determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. this chemical reaction makes it difficult for the magellan lead tests to detect the correct amount of lead in a sample.
the fda recommends laboratories and health care professionals take the following actions:
discontinue using magellan's leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples.
if they are concerned about using the leadcare test systems, the alternative options are mass spectrometry or atomic absorption methods. these are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
for details, please refer to the fda website:
https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm602343.Htm
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm
for information of our previous important safety alert, please refer to mdco website:
http://www.Mdco.Gov.Hk/english/safety/recalls/recalls_20170518.Html
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 march 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: merit 7f prelude short sheath introducers
the united states food and drug administration (fda) has issued a medical device safety alert concerning merit 7f prelude short sheath introducers [lot numbers: h1041469, h1041473, h1036880, h1041464; catalogue numbers: k15-00070, k15-00170, pss-7f-4-035mt, pss-7f-4mt; manufacturing dates: 23 nov 2016 to 30 nov 2016; distribution dates: 15 dec 2016 to 18 jan 2017], manufactured by merit medical systems, inc.
the manufacturer is recalling the prelude short sheath introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure.
if this occurs, the tip could enter the patient's bloodstream. this may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
the manufacturer advises users to quarantine and discontinue use of the affected products and return them to the manufacturer.
for details, please refer to the fda website:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm549795.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 31 march 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: merit 1ml medallion syringes
medical device manufacturer, merit medical systems, inc., has issued a medical device safety alert concerning its 1ml medallion syringes. the affected products are identified as below:
catalog numbers: a) k01-05526p; b) k01-07427; c) k01-07477p; d) k01-07930p; e) k02-00565c; f) k02-01260b; g) k02-01331a; h) k04-00748; i) k12-03636; j) mss011; k) mss011-dg; l) mss011-lg; m) mss011-pr; n) mss011-r; o) mss011-y; p) mss011-yp.
lot numbers: a) h1258821; b) h1263015; c) h1242962, h1246807; d) h1246733; e) h1258361; f) h1258575, h1265248; g) h1252652; h) h1258488, h1264381; i) h1258530; j) h1242750, h1246807, h1255504; k) h1246809; l) h1246810; m) h1242752; n) h1242752, h1255507; o) h1246811; p) h1242927.
the manufacturer is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip.
according to the manufacturer, prior to use and during prep, when fluid is drawn into the syringe, air may enter the barrel and/or fluid may leak out the back of the barrel. this may result in a minor delay in procedure and user dissatisfaction. it has not received any reports of patient harm or injury as a result of this issue.
the manufacturer has chosen to remove the units from the market.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 5 march 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of merz aesthetics' radiesse dermal filler the department of health (dh) today (november 25) instructs a local medical device distributor, dksh hong kong limited (dksh) to recall from users and consumers all affected batches of 1.5cc radiesse dermal filler syringes manufactured by merz aesthics (ma) in the us because of a quality defect with possible safety threat.
dh first came to learn of the incident through its surveillance scheme on medical devices. it was noted yesterday (hong kong time) that the us food and drug administration (fda) has issued an enforcement report about a trade-initiated global recall of the above product, ongoing since this august.
"ma is recalling the product because it has identified a defect in certain lots such that the dermal filler may leak pass the plunger at the proximal end of the syringe when in use," a dh spokesman explains.
"messy aside, microbial contamination and hence resulting hygienic deficiency, and even infection can then become very real concerns. regarding the latter, it is a little reassuring to find that thus far, there is no report of related adverse event anywhere," the spokesman states.
in response to the gap between recall commencement and reporting, the spokesman comments that dh also notes that this has been an ongoing us practice.
"regardless, our officers begin investigation immediately. enquiry into ma's regional representation in singapore reveals that there was history of hong kong having imported the affected batches, with dksh as our local distributor," the spokesman continues.
the spokesman reveals that dksh tells dh staff that it is only responsible for delivery. clients actually placed orders with ma's regional representation in singapore directly.
"further investigation into dksh's trade record shows that it has distributed two of the affected batches (numbers: 1023912 and 1023913) , comprising about 1000 pieces, to the prince of wales hospital (pwh) and another business, micromed limited between march and may this year," the spokesman quotes.
"in view of the quality defect identified, particularly that consequential safety threat cannot be ruled out, we urge that use of the incriminated batches be ceased with immediate effect. to curb further use, we have also directed dksh to collect the remaining stocks from pwh and micromed. in addition, we will also advise the latter to contact their clients for possible checks on ill effects besides putting them under medical surveillance," the spokesman remarks.
"in case members of the public still have the products in their possession, they can either return them to dksh or to dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai. dksh has already set up a hotline at phone number 2895 9302 to handle public enquiry," the spokesman states.
the spokesman also reminds that anyone who is not clear or feeling unwell after having used the product should consult their healthcare professionals.
meanwhile, investigation continues.
ends/friday, november 25, 2011.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: miltenyi biotec life 18 apheresis system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning life 18 apheresis system, manufactured by miltenyi biotec.
tests in laboratory have shown the possibility that under certain circumstances the life 18 apheresis unit will not interrupt the treatment and stop all pumps if a blood leak occurs in the tubing of the disk separator. according to the manufacturer, this type of a severe blood leak in the fluid path of the disk separator during a treatment has been observed for the first time in more than 30.000 treatments performed with the separator.
the manufacturer is developing revised software which will be able to correct the gap in the blood leak detection of the life 18 apheresis unit. as an intermediate preventive action, the manufacturer advises users of the followings:
make sure that the patient connected with the life 18 apheresis unit never remains unattended during the treatment.
check for tubing set integrity regularly during the treatment.
when the blood leak is detected, users should stop the treatment and replace the defective separator.
for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362398
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 22 january 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: mitsubishi vero /mhi-tm2000 linear accelerator system with software version 3.0.0 and after
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning vero /mhi-tm2000 linear accelerator system with software version 3.0.0 and after, manufactured by mitsubishi heavy industries ltd.
accordingbased on internal investigation, the manufacturer found incorrectness with the condition set for rescheduling untreated fractions after the calendar setting is made.
the record and verify system (r&v system) of the vero /mhi-tm2000 linear accelerator system has a calendar function used for treatment scheduling. because of a software bug, an unintended fraction is added to treatment schedule when holiday/workday setting is changed.
according to the manufacturer, in case an added fraction is not detected by the user, unnecessary dose for the fraction will be given to the patient. it can cause death or serious injury of a patient depending on the treatment.
the manufacturer advises users not to change calendar setting - from workday to holiday or vice versa - in r&v system until correction becomes available. however, if users must change the calendar setting, they must confirm whether any treatments, which are to be completed on the day that change is made, are added to each patient’s treatment schedule list as well as correct it manually when they find incorrect rescheduling.
in addition, if users have to change treatment schedule in r&v system, the manufacturer reminds them to double-check the number of the fractions, date and time of the schedule each time until correction becomes available. if any unintended fraction is detected, it should be corrected manually.
the manufacturer will contact all affected customers to schedule its installation. the tentatively planned availability date is end of august 2014.
the manufacturer is creating a software tool to automatically check inconsistencies of patient treatment fractions in r&v system database. if an inconsistency problem is found, the manufacturer will further investigate it in collaboration with the customer to determine whether a potential mistreatment exists.
for details, please refer to mhra website: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con435839.Pdf
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 july 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: moog curlin intravenous administration sets
the united states food and drug administrations (fda) has issued a firm press release concerning the voluntary recall of selected curlin intravenous administration sets, sold and distributed in the united states between december 2011 and may 2012 and manufactured by moog medical devices group.
the manufacturer found that use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. customer complaints have identified three out of 544,900 suspect sets manufactured for the united states. so far, the manufacturer has not received any reports injury or death as a result of this issue.
for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm305208.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 24 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: moog microbore administration set and epidural administration set
the united states food and drug administrations (fda) has issued a class i recall concerning non-dehp microbore administration set and epidural administration set (model no: 340-4114, 340-4115, 340-4126, 340-4128, 340-4128-v, 340-4130, 340-4130-v, 340-4137, 340-4144, 340-4165, 340-4166, 340-4173, 340-4133, 340-4176), manufactured by moog medical devices group.
the manufacturer became aware via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
for details, please refer to fda website
http://www.Fda.Gov/safety/recalls/enforcementreports/ucm307229.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 8 june 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Health canada type i recall: zevex ambulatory infusion pumpspainsmart iod, 6000 cms, and 4000 cms
it has come to our attention that the health canada has issued a type i recall to remind healthcare providers and patients that painsmart iod, 6000 cms and 4000 cms (ambulatory infusion pumps), which are manufactured by zevex inc. (also traded as moog medical devices group), may give an inaccurate infusion.
the accuracy of infusion with a syringe varies widely depending on the medication and stiction between the barrel and plunger of individual syringes. the effects of the variables have made the accuracy difficult to evaluate as each condition produces differing effects from the syringe variables. therefore, zevex is not confident in providing accuracy percentages for syringes as they may be misleading if the application conditions are also considered. as a result, the labeling will be modified to indicate the accuracy of delivery from a syringe cannot be guaranteed.
for details, please refer to the health canada website:
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/
rec-ret_md-im_date_oct-dec_2011-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nal von minden nadal hcg pregnancy rapid test
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning nadal hcg pregnancy rapid test [item number: 142002; lot numbers: all], manufactured by nal von minden gmbh.
this safety notice concerns the limitations of the nadal hcg pregnancy rapid test, which is calibrated for intact hcg and detects intact hcg only.
the proportions of intact hcg and other hcg forms in serum and urine may differ according to the stage of pregnancy in which it is analysed. according to the manufacturer, in rare cases, at a more advanced stage of pregnancy (approximately week 5-8 of pregnancy), increased amounts of hcg-beta-core fragments may be present in the urine hindering the detection reaction and leading to false negative results in spite of high hcg concentration.
customers are advised to pay attention to this further limitation when evaluating the test result.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notices-19-december-23-december-2016
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 4 january 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: natus medical olympic cool-cap® system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning olympic cool-cap system, manufactured by natus medical incorporated.
the manufacturer of the device has initiated two separate field actions.
the first action applies to all olympic cool-cap systems. the manufacturer has been informed of a small number of instances where the olympic cool-cap system’s control module has experienced a frozen screen during the treatment of infants. when this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infant. although there is an audible alarm that sounds when this occurs, not all users have reported hearing it; the only visible indication on the system screen is that the clock displayed at the upper right hand corner of the screen stops advancing.
the second action applies only to a specific subset of olympic cool-cap systems. the manufacturer has been informed of a small number of instances where the power supply within the cooling module of the olympic cool-cap system has failed. the power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment. in response, natus is proactively coordinating the replacement of power supplies in all affected olympic cool-cap cooling modules.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
posted 29 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: neoss guide – drill-hubs i to v included in neoss guide kit
the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning neoss guide – drill-hubs i to v included in neoss guide kit ø3.5 - ø4.5 (art number 51153), manufactured by neoss. the affected product identifier is 9040, with product numbers (bn) 15182, 15586 and 16030.
according to the alert, the affected batches of drill-hub i may not be functioning as intended. specifically, the drill does not latch completely in the drill-hub i.
the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected.
the manufacturer advises affected users to inspect their stock on hand and to quarantine affected units prior to their return to the manufacturer.
for details, please refer to the tga websites:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00917-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 september 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nestle compat nasogastric feeding tube
it has come to our attention that the medical device manufacturer, nestle healthcare nutrition, inc. has initiated a medical device field safety corrective action concerning compat nasogastric feeding tubes with universal “y” adapter and stretch-lok strap (compat ng tubes). the affected models are compat nasogastric feeding tube 8fr, 10fr and 12 fr. the affected lots are:
08211z, 14212u, 35411h, 02412k, 14611p, 01413g, 08712w, 21512y for compat nasogastric feeding tube 8fr;
08712d , 05312n , 08111m, 10211e, 13712w, 21512f, 01613g for compat nasogastric feeding tube 10fr; and
05912f , 01211av, 04111p, 04111v, 05812f, 21512g, 01513n, 06313n, 23412bv, 34712v, 35411u, 04111d for compat nasogastric feeding tube 12fr.
according to the manufacturer, this recall has been initiated due to the fact that some of the compat ng tubes have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label. the manufacturer assures customers that all compat ng tubes have gone through the sterilization process and there have been no complaints associated with the recalled product. however, the manufacturer is recalling the affected products because the sterility claim on the label cannot be 100% certified and verified.
patient safety risk is considered negligible for the following reasons:
the gastrointestinal tract normally contains many different bacteria species;
nasogastric tubes become non-sterile as soon as they are placed through the nasal cavity;
if brought into a sterile environment such as an operating room because of the “ sterile” labeling, standard operating procedures in those environments would minimize the chance of contamination via gloves or a similar mechanism.
other products on the market with the same intended use are sold non-sterile.
according to the local supplier, the affected products have been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 july 2013 revised on 8 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Mhra issues updates on the use of injectable dermal filler, macrolane for breast augmentation
the medicines and healthcare products regulatory agency (mhra), united kingdom has issued updated information about macrolane, an injectable dermal filler manufactured by q-med.
q-med has decided to discontinue macrolane for use in breast augmentation as the product may interfere with the reading of mammograms and could make diagnosis more difficult. people who have undergone breast augmentation with macrolane should inform the healthcare professional conducting their breast examination of the date of their last macrolane treatment prior to the assessment.
according to the manufacturer and the mhra, there are no safety concerns with the product and the product can still be used in its other indications.
according to the local supplier, the affected products have been distributed in hong kong. for details, please visit the mhra website:
http://www.Mhra.Gov.Uk/newscentre/con149797
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nipro diagnostics truetrack and truebalance blood glucose monitoring system
the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a field safety notice concerning two models of blood glucose monitoring systems: i) truetrack (private label: wellion smart system, stada gluco check); & ii) truebalance (private label: wellion smart system 2), manufactured by nipro diagnostics.
during a specific reconfiguration process in the company’s establishment in florida, usa where unused blood glucose meters in their original packaging are returned from customers and reconfigured with the appropriate unit of measure for a different geographic market to which they will be shipped, the unit of measure was set incorrectly on a small subset of reconfigured truebalance and truetrack meters.
as the result of a process error in the reconfiguration process, certain meters may display: mmol/l as the unit of measure instead of mg/dl; or mg/dl as the unit of measure instead of mmol/l.
for meters with incorrect mmol/l unit: in the event the user is unable to identify that the meter is displaying an incorrect unit of measure (mmol/l), the user may interpret the reading as abnormally low, depending on the user’s actual blood glucose value. based on this sequence of events, the user will not over medicate but may unknowingly remain in a hyperglycemic state.
for meters with incorrect mg/dl unit: in the event the user is unable to identify that the meter is displaying an incorrect unit of measure (mg/dl), the user may interpret the reading as higher or much higher than expected, depending on the user’s actual blood glucose value. based on this sequence of events, the insulin user may over medicate and unknowingly remain in a hypoglycemic state or possibly over medicate, which may result in death or irreversible harm.
there are no reports of adverse events or injury to date.
users are advised to contact their supplier to see if their products are affected and the necessary actions for returning the devices if affected.
according to the manufacturer, the affected products were not distributed in hong kong.
for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con326483
posted on 31 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Recall of restylane subq lidocaine 2ml dermal filler
the department of health (dh) today (february 21) drew public attention to the recall of a dermal filler, restylane subq lidocaine 2ml (batch numbers: 11907 and 11516), due to defects in the sealing of the package which might compromise the external sterility of syringes containing the product.
the dh received notification from the product's local supplier, galderma hong kong limited, that the swedish manufacturer, q-med ab, had initiated a recall of the above product.
"according to the manufacturer, the decision to recall the affected products from the market is due to defects in the sealing of the package. while the sterility of the content inside the syringe is unaffected, defects in the package mean that the external sterility of the syringe can no longer be guaranteed," a dh spokesperson explained.
"further investigation into the local supplier's product distribution records shows that it has distributed the affected products, comprising about 170 pieces, to medical clinics and beauty centres from june 2012 to february 2013," the spokesperson added.
so far, the dh has not received any adverse event reports related to the products. the dh will closely monitor the recall.
in case members of the public have the products in their possession, they can contact galderma on its hotline (2238 0900) for public enquiries.
the spokesperson also reminded the public that anyone who is in doubt or feeling unwell after having used the product should consult health-care professionals.
the dh has informed public and private hospitals and relevant medical associations about the issue.
ends.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nidek medical oxygen concentrators
the united states food and drug administration (fda) issued a class i recall concerning oxygen concentrators manufactured by nidek medical products with model numbers as follows [serial numbers 042-10000 through 102-07044]:
nidek medical mark5 nuvo 8 std, 115 v~60hz - 500w.
nidek medical mark5 nuvo 8 /ocsi, 230 v~50/60hz - 420 w.
nidek medical nuvo lite model 525 ocsi, 115v -60hz - 330w.
nidek medical nuvo lite model 520 std, 115v - 60hz - 330w.
nidek medical nuvo lite model 925 ocsi, 230v - 50hz - 300w.
nidek medical mark5 nuvo / m5c5, 115 v ~60hz - 410 w.
nidek medical m5c5/ mark5 nuvo/std, 230 v~50/60 hz - 420 w.
nidek medical nuvo lite model 925 ocsi, 3lpm 230v - 60hz - 280w.
nidek medical m5c5/ mark5 nuvo/ocsi, 230 v~50/60 hz -420 w.
according to the fda, the reason of this recall was due to capacitor failure which may result in a fire hazard and loss of supplemental oxygen supply.
according to the local suppliers, the affected products have been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted 4 june 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nihon kohden defibrillators cardiolife tec-8300k series
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of defibrillators cardiolife tec-8300k series (model no.: tec-8321k, tec-8322k, tec-8332k, tec-8342k and tec-8352k), manufactured by nihon kohden corporation.
according to the manufacturer, there is a possibility for a limited number of cardiolife defibrillators tec-8300k series that the battery is not charged when the defibrillator is connected to the ac power. the defibrillator can be used in the battery operating mode until the battery is discharged completely. there is no limitation for the operation of the defibrillator when ac power is connected.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/
index.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nihon kohden cardiolife defibrillator, tec-5521k and tec-5531k
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning a potential malfunction of cardiolife defibrillator (model tec-5521k and tec-5531k) using a software version ≦ 01-20, manufactured by nihon kohden corporation.
during operation the defibrillator in battery mode there are several battery alarms when reaching critical levels of the battery capacity. when the battery alarms are ignored and the battery is discharged continuously, the defibrillator shut down automatically. in rare cases this could lead to a damage of the power control circuit and the defibrillator could not turn on either in battery mode nor in ac power mode again. this defect requires maintenance of the defibrillator by the authorized service partner. the frequency of the reported incidences caused by this malfunction is approx. 0.017%.
the manufacturer advised users to make sure that the battery of the defibrillator is charged completely always and that the battery test and the exchange of the battery is performed regularly according the instructions in the operator’s manual and follow the instructions related to the battery alarms. this avoids the automatically shut-down of the defibrillator.
also, the manufacturer will eliminate this potential malfunction to the affected defibrillators by the installation of a software upgrade with an improved algorithm for the automatically shut-down of the defibrillator when the battery is discharged completely. this software upgrade will be installed by the manufacturer during the next regularly maintenance.
for details, please refer to the mrha website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con203860
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 november 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nipro europe nv sureflux 25ux lc ga
medicines and healthcare products regulatory agency (mhra), united kingdom, has posted a field safety notice concerning sureflux 25ux lc ga [lot numbers: 14i29f, 14l29f, 15b23f, 14i29f], a dialyzer manufactured by nipro europe v.
the manufacturer received complaints from the japanese market regarding a housing body crack of dialyzer and a leakage of the saline or dialyzer solution. the position of the crack is near its header position.
the manufacturer found that the housings were misaligned because auxiliaries were bumped unintentionally into auxiliary removing device set before roughly-cutting process. due to this, misaligned housings were contacted by holding jig at the next process and cracks were generated around the dialysate ports.
according to the manufacturer, there was no adverse event or health injury related to this problem having been reported so far.
the manufacturer is recalling the affected product and users are advised not to use the affected lots.
if you are in possession of the affected products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: nitinol devices & components hydrofinity hydrophilic guidewire
the united states food and drug administration (fda) has issued a medical device safety alert concerning hydrofinity hydrophilic guidewires, manufactured by nitinol devices & components, inc.
the manufacturer announced a voluntary recall of the hydrofinity hydrophilic guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. vessel occlusion may necessitate surgical intervention to resolve. two cases were reported where the polymer jacket separated from the device and embolized. one case required surgical intervention.
for details, please refer to the fda websites:http://www.Fda.Gov/safety/recalls/ucm401753.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 june 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: etac avant, avant lw and salsa
it comes to our attention that there were 4 registered incidents involving the walker avant and 1 registered incident involving the walker salsa manufactured by etac supply center due to wheels coming off in ten year period.
when delivered from etac, the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. the lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. when assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and then cannot be fastened properly. another error may occur if the lock ring is mounted without ensuring that it fits into the groove all the way around the axle. both of these assembling errors may give the impression that the wheels are properly fastened, but such wheel can come off if it gets struck or hits an obstacle that affects the wheel sideways.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: etac swift mobil shower chair
it has come to our attention that medical device manufacturer, etac supply center ab has issued afield safety notice regarding all swift mobil shower chairs with serial number 3829 to 11028.
the manufacturer has received information from a few users of malfunctions with the swift mobile shower chair. it was reported that the casters in some cases are loose and in a few cases has fallen off. the manufacturer is unaware that loose casters would have resulted in any harm or serious injuries. there is however a potential risk for harm and injury if the shower chair loses a caster and thus instantly becomes unstable.
the manufacturer has after thorough investigation concluded that several root causes has contributed to the reported loosening of casters. the required torque for the caster fastening screws to the frame has in some cases not met the factory specifications.
therefore, the manufacturer will replace the casters of the affected shower chairs to ensure a continuous long term safe use.
also, the manufacturer advised that there are no reasons for an immediate stop of using the affected product, however as an intermediate precautionary action awaiting the caster replacement, user facilities are requested to be observant and inspect the casters to see if there are visible signs of a caster coming loose.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 22 november 2012.