Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Two issues have been identified with the plum 360 infusion system involving the distal occlusion auto restart (doar) feature and preventative maintenance (pm) due notification.Issue 1 - if the doar feature is enabled and a distal occlusion occurs, the pump will be in a "paused" state. if a malfunction alarm occurs while the pump is in the paused state waiting for the distal pressure to decrease, the pump cannot be turned off nor delivery restarted until the battery is discharged or disconnected. once the battery is recharged or reconnected, the pump can be returned to clinical service.Issue 2 - when the pm screen is accessed from the main biomed settings menu on pumps that have accumulated a total delivery time greater than 1500 hours, the user will not be able to interact with the pump and the pump must be power cycled. once this is done, the pump can be returned to clinical service. there have been no reports of a serious injury or death related to these issues.
Acción
For Issue 1:
Hospira is providing work around instructions for users to follow as a interim measure.
For Issue 2:
Hospira is advising users to not enable the optional Preventative Maintenance Due Notification feature.
A software update will be implemented as a permanent correction.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Causa
Icu medical has identified issues with hospira labelled mednet medication management suite versions 6.1 and 6.21 when used with plum 360 drug library management that occurs during the import of a plum 360 drug library.The mednet meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. this includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback.A change to a piggyback rule set could result in a delay initiating a therapy or interruption of an active infusion. this issue could also lead to mixing of two infusion solutions. if two mixed solutions are incompatible particulates could form or, if during a transfusion, a blood clot could form in the administration set. in rare circumstances, these conditions could lead to serious adverse health consequences.
Acción
ICU Medical is advising users that the issue arises during an import of a Plum 360 drug library. Users who have performed an import of a Plum 360 drug library or have the need to do so should refer to the information provided to customers to confirm if the drug library is affected during the import. A correction to the issues will be addressed in MedNet version 6.3.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has determined that a laser marking machine used to create the distance markings on the tip of the thoracic pedicle feeler has settings higher than those intended. this change leads to an increased energy being directed onto the tip of the thoracic pedicle feeler, causing material degradation where the laser marks exist.There is the potential for the tip of the thoracic pedicle feeler to break during use. if this occurs within the patient, migration of the broken tip could result in soft tissue or peripheral nerve injury requiring surgical intervention.
Acción
Stryker is advising users to quarantine any affected product and contact their local Stryker representative to coordinate the return and replacement of affected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Fresenius medical care australia have identified that a specific procedure pack contains a wrong component. there is a 5008 bibag 900g within the pack, when it should contain 4008 bibag 900g.
Acción
Fresenius Kabi is advising users to inspect stock and quarantine the affected units. Affected packs will be replaced with unaffected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
During internal pressure (leak) testing of the affected product, failures related to the tip seal leak were identified by getinge. this issue at the catheter tip seal could potentially cause a leak in the balloon and may lead to an interruption of therapy resulting in the need to replace the defective iabc with a new catheter. such occurrences could cause momentary haemodynamic instability in a patient, or potential complications related to vessel bleeding related to replacement of the iab catheter.To date, there have been no reports of serious injury.
Acción
Getinge is advising users to quarantine any remaining stocks of the affected product for return.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker has conducted a review of the currently available data of the stryker rhead radial head and uni-elbow system, and it was found to be inconclusive to continue supporting the performance of the device. the system is intended for replacement of the proximal end of the radius. this includes replacement of the radial head for degenerative or post-traumatic disabilities, presenting pain, crepitation and decreased motion at the radio humeral and/or proximal radio ulnar joint with joint destruction or subluxation visible on x-ray and resistance to conservative treatment.Post-operatively, the following may occur; implant loosening (septic and aseptic), instability (mod-severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement and heterotopic ossification.
Acción
Stryker is advising customers to inspect inventory for affected product and quarantine it immediately. Stryker will arrange collection of goods from affected sites.
Health care professionals that have patients using the Stryker rHead Radial Head/Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care and be aware of this issue when doing so.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge healthcare has recently become aware of a potential safety issue with the 3.0t 6 channel flex coil used with the 3t mr750w surgical suite scanners. coil overheating can occur when the device is used in mode 2 setup. this could lead to a serious patient thermal injury.To date, there have been no injuries reported as a result of this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
Acción
GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
In march 2017, siemens healthcare issued an urgent recall for product correction vc 17-04 (tga ref: rc-2017-rn-01350-1) regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension and dimension vista assays. the ongoing investigation by siemens has identified the following new information regarding biotin interference:1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the affected assays. these concentrations of biotin can potentially result in interference >10%; and2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin can potentially result in interference >10%.Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. the probability of misinterpretation of results due to this issue is unlikely.
Acción
Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Teleflex has identified certain lots of weck auto endo5 automatic hem-o-lok clip appliers have a nonconformity that may cause clips to misload, jam, or fall out of the applier. there could be a delay in procedure if an applier becomes jammed or if a clip falls out of an applier.
Acción
Teleflex is advising users to inspect stock and quarantine all units from listed product and lot numbers. Teleflex will arrange collection of product from affected users.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer, bard medical division (bmd), has identified specific lots of bard arcticsun articgel pads that have insufficient adhesion of the hydrogel to the pad, which has the risk of the hydrogel peeling away from pads during the removal of the release liner.
Acción
Bard is providing customers with additional instructions for use to identify the potential issue, and provide guidance to allow the product to be used in a normal manner.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens has identified a potential risk of unnecessary radiation exposure due to a software issue in the care dose4d algorithm implemented in specific siemens ct scanners. this relates to possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. potentially, the care dose4d software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. accordingly, siemens strongly recommends using topograms in lateral position for all head scans.
Acción
Siemens is advising users that the described issue will not occur when using a lateral topogram instead of a.p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans.
Siemens will be providing a software update as a permanent correction.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
In april 2017 (tga reference rc-2017-rn-00500-1) beckman coulter advised customers of issues with the access br monitor relating to results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).As a follow up, beckman coulter will update the access br monitor instructions for use (ifu). the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.
Acción
Beckman Coulter is advising users of the updated 95th percentile upper reference limit (URL) value for a healthy population, which is 23.5 U/mL.
Beckman Coulter is recommending that users review the contents of this letter with the Laboratory Medical Director. This URL change may mean that some patient test results should be reassessed depending upon how the URL is established by the laboratory.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Seqirus has received notification that epiclone anti m lot 009817601 is showing false positive m reactions with m negative control cells in cat (column agglutination technology) biovue cards. investigational testing by seqirus suggests that there is an incompatibility between anti-m lot 009817601 and the cat biovue cards.
Acción
Seqirus is advising customers to only use the product for phenotyping via the Tube method. Users should not continue use of the product with Column Agglutination Technology (CAT) Cards. Seqirus is advising laboratories to perform a review of previous positive reactions obtained where CAT Cards have been used with Epiclone Anti M Lot 00981760.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Livanova is issuing a recall for product correction to inform users about the retrofit of their heater cooler 3t devices to implement a vacuum and sealing upgrade. this modification to the internal design of the 3t heater-cooler device will collect any aerosols that are potentially contaminated with nontuberculous mycobacterium (ntm), preventing those aerosols from entering into the sterile operating field.Livanova is also notifying that the 3t device will be suspended from the australian register of therapeutic goods (artg) beginning 8 november 2017 for a period of up to 6 months. the reason for this suspension is that the minncare disinfectant is not listed on the artg with the same classification as the 3t device. however, during this period, livanova will be able to supply loan units on an as-needed, no-charge basis to ensure continuity of clinical practice.
Acción
LivaNova has completed the development of a TGA approved correction that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. This correction will be implemented by an onsite enhancement of units currently in use by LivaNova service personnel or a local agent. Although this issue is less likely when the 3T device’s water system is maintained according to the current IFU, this product correction will mitigate against the reasonably foreseeable hazard of patient infection which may be potentiated by poor maintenance practices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Elekta have identified that it is possible to get a positional error with the precise treatment table following automatic table movement. this can occur if there is an undetected failure of the positional sensors. this has been previously communicated through notification 200-01-204-011 (rc-2014-rn-00927-1).It is possible to deliver treatment with the patient in an incorrect position, if this fault were to occur and go undetected.
Acción
Recipients should distribute this notice to all users of the system and include a copy of the notice with the system manuals.
The supplied Field Safety Notice serves to reiterate the importance of a procedure to check for the error already present in the IFU, previously communicated to customers (TGA Ref: RC-2014-RN-00927-1). Users should continue to follow the recommended daily QA checks detailed in the IFU, also present in the previous Field Safety Notice, until the software upgrade is released.
Acknowledge the receipt of this notice by completing the Confirmation of receipt form you receive from Elekta's automated distribution system. Please return the form to Elekta even if you no longer have the affected units at your site.
Elekta will release Integrity™ R4.0.0, which will identify positional errors over 5 mm if a sensor has failed. Upgrades in the field are expected to start in the first half of 2018. Elekta will contact users to plan and schedule this upgrade.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Johnson & johnson vision care (jjvc) has identified quality issues identified with specific batches of acuvue contact lenses. a limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”. foreign matter - a limited number of reports of a brush bristle found between the blister package and foil have been received.Off power - a limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). not all lenses in these lots are affected and there is no significant health risk related to this issue.To date, there have been no adverse events related to these issues.
Acción
Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Johnson & johnson medical (jjm) has identified an issue with the acetabular cup introducer (32mm) where the nylon ejector slug may melt during the autoclave process. this may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement.
Acción
JJM is requesting Customers:
1. Immediately inspect the device(s) in your possession to determine if your facility has affected product. If you do please quarantine this product prior to returning it to JJM;
2. Return a copy of the supplied acknowledgement form, even if you do not have any affected product, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com;
3. Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service on 1300 562 711;
4. Forward the recall notice to anyone in your facility who needs to be informed; and
5. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer pro med instruments (pmi) has been made aware of two breakages of the doro sterile disposable skull pins at the tip, which occurred during two surgical procedures. the breakages occurred at the very distal end of the conical part of the skull pin tip. these breakages did not cause any injury to the patient and pmi have not, to date, been made aware of any further adverse events.In a worst case scenario, this issue could lead to slippage which may require remedial action, loosening of the positioning and a delay in surgical procedure or the tip remaining in the skull, which could lead to subsequent complications such as wound healing.
Acción
Life Healthcare is requesting customers:
1. Review the Sponsor supplied Customer letter and ensure all users of the device are informed of this recall. If you have transferred the affected items to third parties, forward a copy of the Customer Letter to them;
2. Check your stock for affected Doro Pins Ref: PMI-3006-00 Lot 1704;
3. If you have affected items quarantine them immediately and complete the relevant section in the supplied form;
4. Check any records where the affected lot numbers have been used prior to this notice for discrepancies in the skull pins. If the tips have been noted as not being intact ensure that any remaining pieces are removed from the patient; and
5. Please complete the supplied reply form and return by email to regulatory@lifehealthcare.com.au
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips have identified multiple issues with the philips brilliance 64 / ingenuity family running software version 4.1.6issue 1: cardiac signal not found in workflow issueissue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to startissue 3: pulmo gates on cardiac workflow issueissue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well.Issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results issue 6: application may fail when modifying the results plan box during 3d calcium score issue 7: tube too hot issue 8: memory overflow issueissue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error messageissue 10: issue with the generator monitor state machine in rhost code issuethere have been no injuries reported as a result of these issues.
Acción
Philips is providing users with work around instructions to follow as an interim measure. Philips will be performing a software update as a permanent correction.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Physio-control is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by cardinal health, does not meet physio-control’s specifications, and shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. if the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. this may result in failure to defibrillate and serious injury or death. there have been no reports of injuries associated with this issue.
Acción
Users are advised to inspect the "Electrode pouch and box labelling" and the "Electrode Starter Kit box labelling" to determine if the electrodes are affected. Users are advised to place of copy of the correct electrode packaging and labelling with each affected AED, until the electrodes have been replaced by Physio- Control.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Cook medical has identified that the labels of specific lots of disposable reuter tip-deflecting wire guides do not explicitly state that they are heparin coated. the products are labelled with the correct catalogue identifier, which includes the suffix “bh” that indicates the product is heparin coated. however, users who are not familiar with the “bh” nomenclature may not be aware that the product contains heparin.To date, no adverse events have been reported due to this issue. under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of heparin induced thrombocytopenia (hit). either of these situations could potentially result in serious injury or death.
Acción
Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Boston scientific is initiating a removal from the market of the150mm eluvia drug-eluting vascular stent system and the 200mm innova self-expanding stent system due to elevated complaint rates for partial stent deployment.There have been 190 complaints of partial deployment. partial deployment occurs when the stent is unable to be fully released from the delivery system. part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. the most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. however, boston scientific has received reports in 14 cases of major surgery to retrieve the stent/delivery system or to correct vascular compromise.
Acción
Boston Scientific is advising users to inspect stock and quarantine the affected products for return for credit.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Baxter has been made aware of a recall initiated by smiths medical australasia of certain lots of 50 and 100ml cadd medication cassette reservoirs (non-flow stop) as they may have been manufactured with an incorrect pressure plate. baxter has identified some of the affected batches have been used to prepare compounded medications supplied to customers.
Acción
Baxter Healthcare is advising users to inspect stock and quarantine affected units. Baxter are re-issuing required cassettes, if required.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Pyramed has identified a potential problem with the y connector detaching from the outer sheath of the device. this may result in the balloon remaining partially inflated in the patient and this may require manual and/or surgical retrieval.
Acción
Pyramed is advising customers to isolate affected stock from inventory. Pyramed will arrange for collection and replacement of affected devices.