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
There have been reported incidents of a distar crt monitor that has fallen off the monitor suspension related to product ageing. a fall of a crt monitor could result in a serious injury to a patient or operator. crt monitors, crt monitor feet, and crt suspensions systems have exceeded their nominal life and are obsolete.
Acción
GE Healthcare will correct all affected products. A GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised of the following:
- The CRT monitor & suspension should be inspected & used with caution. Make sure the monitors are secured properly to the tray before each use. Immediately stop using the system in case of any looseness of the monitor noticed contact your GE service representative.
- Monitor should not be positioned directly above the patient.
- Position the monitor by grasping the handle at the side or front of the tray & gently move to position as recommended in the User Manual 45-296411.
- Before service / preventative maintenance of the monitor is attempted on a GE system by non-GE service personnel, GE strongly recommends that they obtain an updated copy of the service and preventive maintenance procedures from a GE Healthcare representative or download from the GE On-Line Documentation website.
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 formula of doubling time is incorrectly defined in lung nodule analysis (lna). this may result in the wrong calculation result of doubling time, which may lead to misdiagnosis. lna is an optional tool that is only featured on mx 16-slice systems with software version 2.0.
Acción
Philips will upgrade the system software and replace the software discs free of change. Before the software is upgraded, customers are advised not to refer to the parameter of “Doubling Time [day]” in Lung Nodule Analysis, instead refer to the parameter “Growth Rate [%]” for the growth of nodules.
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
Medtronic is writing to inform physicians about a software issue that could result in the loss of lv pacing that occurs following a specific device programming sequence. if it occurs, this issue can be corrected by re-programming the device. all tachyarrhythmia detection and therapy features remain fully operational. the issue can only occur in devices that have been programmed from managed ventricular pacing (mvp) mode to a pacing mode with adaptivcrt enabled. when a patient with adaptivcrt enabled (shipped setting) is subsequently programmed to mvp mode and then re-programmed back to ddd or dddr, adaptivcrt is not re-enabled. when this programming sequence occurs, lv pacing is not delivered, despite parameters indicating adaptivcrt is enabled. through 10 november 2016, two events have been reported to medtronic related to this issue. a review of the data revealed an overall occurrence rate of 0.38%. medtronic has not received any reports of patient injury related to this issue.
Acción
A software update is being developed by Medtronic to address this issue in Claria MRI and Amplia MRI devices. This software update will also address an unrelated transient mode switch behaviour in all Quadripolar models of Claria MRI, Amplia MRI, and Compia MRI CRT-D SureScan devices. Further information will be communicated once the software update receives applicable regulatory approvals. Until the software update has been approved and the affected models receive the update, Physicians are advised to follow the programming recommendations in the customer letter. These recommendations also apply to any new device implants.
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
Bard access systems has recently become aware that some statlock catheter stabilisation device single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).If the statlock were used beyond its expiration date and became unstable, it may provide sub-optimal securement or stabilisation.
Acción
Customers who have purchased the affected stock are being provided with the missing unique product identifiers (product code, lot number, expiration date, etc.). This action has been closed-out on 25/05/2017.
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
Reports have been received of leakages between the spike port and the drip chamber spike of the smart site add-on bag access device. separation and leakage between the spike port and the drip chamber spike may occur during infusion. to date, there have been no reports of serious injury or death in australia associated with the separation or leaks.
Acción
CareFusion is advising customers to quarantine affected stock. Customer Service will then arrange for the pick-up of the affected stock and issue a replacement or an account 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
During the continuous monitoring of sleep safe tubing systems on the market, fresenius medical care has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes, and thus leakages may occur. the possible damage might not be visually detected. the sleep safe cycler can also not detect such a leakage. therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis. the problem of overwelded lines has been analysed and solved in subsequent production.
Acción
Fresenius will be contacting patients (users) via hospitals and organising the exchange of potentially affected stock with replacements. In the interim, users are to follow the detailed handling instructions provided in the customer letter. Users are reminded to: - Unroll carefully the tube coils of the sleep safe sets. - If unrolling is not possible, discard the sets. - If unrolling is successful, check carefully the patient line for leakages during priming. For more information, please refer to https://www.tga.gov.au/alert/sleep-safe-tubing-systems-used-peritoneal-dialysis .
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
An issue has been identified where the defective labels may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
Acción
Hill-Rom is advising customers to inspect and quarantine affected stock. Replacement with unaffected goods will take place.
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
A complaint has been received that on the box label, the country of manufacture ("made in usa") was incorrectly labelled as “made in switzerland” and was missing the ce mark as well as the european authorised representative (“ec rep”) address.
Acción
Stryker is advising customers with affected stock to return them for replacement or 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
In dec 2015, dräger informed users of an error condition observed with the oxylog 3000 / oxylog 3000plus (tga ref.: rc-2015-rn-01256-1), where the loss of contact of one of the control knobs generated an error message (previously referred to as "poti unplugged"). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure & the ventilation function stops operating. investigations indicated that the error condition was caused by an oxide layer in the potentiometer. these oxide layers may accumulate over a longer period of time where various factors collude (i.E. if the knobs are moved rarely or never). as communicated previously, a verified remedy is repeated twisting of the knobs that removes the oxide layer. whilst the remedy of twisting the knob is still considered effective, to reduce the impact of this error condition dräger has developed new software.
Acción
Dräger has developed a new software that reduces the impact of the error condition i.e., software version 1.06 will be introduced for the Oxylog 3000plus and software version 1.23 for Oxylog 3000 respectively. A Dräger engineer will contact affected customers directly to schedule the software upgrade. Whenever a "control knob faulty" condition will occur with a device being equipped with the new software, the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for VT and post the corresponding alarm. As reflected in the amended Instructions for Use Manual, users are advised to check the patient’s condition and the ventilation.
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
Beckman coulter has determined that certain lots of dxc wash concentrate ii can cause a failure in calibration of thermo-fisher lithium reagent (ref a19611). the consequence of calibration failure does not allow for patient results to be generated. lithium calibration failure can potentially lead to a delay of reporting lithium results. patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
Acción
Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not 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
Baxter healthcare has identified, during post-market surveillance activities, the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. inadvertant disconnection of the bloodline from the patient access site due to an improper connection of the access line could result in serious adverse health consequences such as an air embolism and/or blood loss. baxter has received sporadic events reporting of inappropriate connections between the bloodline and the patient access site, resulting in external blood loss for the patient.
Acción
Baxter is providing users with additional instructions on how to properly connect and to avoid a disconnection, as follows:
1. Insert the male luer cone in the female connector. Stop upon perception of complete adherence between the two components.
2. Screw the male luer coupling nut on the female component until perception of the end stop.
3. After the connection is completed, check that the male luer coupling nut is firmly screwed.
During the whole connection procedure for both arterial and venous patient lines (red and blue coupling nuts), hold and screw the male luer coupling nut only. Do not apply the screwing torque to the male luer body.
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 barcode and value sheet for a single lot of precicontrol varia contain an erroneous target value for control level 2, when used with certain lots of elecsys pth assay on cobas e 411 analyser. the deviation between the correct & erroneous value is 20% for pth lot 185000 & 31% for pth lot 143251. this issue can be detected because it will cause elevated level 2 control recoveries. also it can be detected if both control levels 1 & 2 are run prior to measurement of patient samples. if only control level 2 is used and a local issue occurs in the lab where false-low pth results of -20% to -31% are obtained, the control would be within range and consequently false-low results could be reported. in an intra-operative measurement scenario, an erroneous low pth result can result in an incorrect conclusion that tumour resection was complete. in the worst case, remaining cancerous or hyperplastic tissue may be left undetected. to date, no customer complaints have been received by roche.
Acción
Roche is providing users with the correct control level 2 target values for the PTH assay on an updated value sheet. The correct target value is to be manually entered by the user, noting there is a reagent lot-specific value for Elecsys PTH lot 143251 and for other lots the PTH value target value should be used as per routine operation. This action has been closed-out on 25/05/2017
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
An issue has been identified regarding rf projection images (12 diacom sop classes). if user measures on rf image, “cal” (calibration) is not displayed & measurement is not correct, then the “cal” label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing. measurements are incorrect because efilm is using the imager pixel spacing dicom tag, but it should be using the pixel spacing tag if the value for pixel spacing is present & is differing from imager pixel pacing tag. based on industry practice for projection images, if both the imager pixel spacing and pixel spacing attributes are present and differ, the pixel spacing attribute should be used and the "cal" (for calibrated) label should be displayed.A user will likely be able to notice that the measurements are not as expected. potential health consequence includes delay in patient care and/or change in recommendation for treatment.
Acción
Merge has released a software fix for this issue. The software can be downloaded from its website. Users are advised that they must discontinue using eFilm Workstation/eFilm Lite for viewing of projection images for the affected SOP classes listed in the customer letter until the upgrade is installed and in use.
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
Following a customer complaint about the e.To.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. a failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:- an increase in the surgery timeline if the incident occurs at the beginning of the surgery.- a risk of injury for the patient if the incident occurs during surgery.There have been no reported patient injuries. as a precautionary measure, amplitude decided to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.
Acción
Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.
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
Ortho clinical diagnostics (ortho) has identified the potential for biased urine protein results using vitros upro slides. the following observations were made when using vitros upro slides:-1. variability gen to gen for patient samples. impact to results: magnitude of bias is dependent upon the gen;-2. variability in results for random and 24-hour urine samples with low specific gravity. impact to results: unexpected increase in the number of results exceeding the reference intervals for random and 24-hour urine samples.; and-3. negatively biased results. impact to results: negatively biased results versus the ortho pyrogallol red comparative method.Ortho is providing users with the results of their internal testing that details the levels of bias observed for each of the scenarios above.Gens 12-18 are affected, however the gen 12 and 13 product have expired.
Acción
Ortho is advising users to immediately discontinue using and discard all VITROS UPRO Slides remaining in their inventory. Ortho will credit accounts for any discarded VITROS UPRO Slides and VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Any concerns users may have regarding previously reported urine protein results should be discussed with the Laboratory Medical Director to determine the appropriate course of action. As Ortho is unable to provide replacement VITROS UPRO Slides at present, they recommend laboratories use an alternative method until further notice by Ortho of future product availability.
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 regular field observations siemens have identified a software issue with two possible, mutually independent causes of a system defect, these are as follows:1. in artis systems with a100plus or a100g generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator; and2. for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.Siemens advises they do not consider it necessary to re-examine any patients in this case and that this is a possible hardware defect that has no influence on the treatment of patients.A system software update will implement additional protective mechanisms for the generator and correct the software problem.
Acción
Siemens will be contacting affected users to arrange a date to perform a system software update, which will implement additional protective mechanisms for the generator and correct the software problem.
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
Depuy synthes trauma has received product complaints for breakage in the pfna blade impactor, where the handle detached from the shaft of the instrument. it has been identified that a laser weld breakage, partial or complete, can occur in the pfna blade impactor where the handle detaches from the internal shaft of the instrument.In the event that the laser welding of the handle cracks, the handle may loosen or separate from the instrument. if the issue is detected during use, a marginal surgical delay may occur if the handle cracks, loosens, or separates. infection could potentially result if the handle is loosened from the shaft and allows body fluids (i.E. blood, bony debris) to enter the interior of the impactor’s handle.
Acción
Customers are advised to immediately quarantine the product and return it to JJM. If they have any questions about alternative devices, they are advised to contact DePuy Synthes Trauma.
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
For certain lots of set screw, the manufacturer has become aware of a trend specific to set screw postoperative disengagement from the screw body (set screw back-out). 16 complaints were received from october 2015 through august 2016. in the short term, there is a risk that set screw post-operative disengagement from the screw body at the end of a construct may lead to hardware failure and/or pedicle screw pull-out on adjacent levels, and may also lead to revision surgery. the long term risk is that set screw post-operative disengagement from the screw body may lead to loss of correction, as well as the non-union/non-fusion of bone (pseudoarthrosis). there is also an unrelated issue for other lots of set screws where a small proportion of lots were manufactured in an oversized condition. for this issue, testing conducted by alphatec indicates that if the set screw is successfully inserted and locked to the required tightening torque, the construct will perform appropriately.
Acción
For the screw back-out issue, implanting surgeons are being informed to consider more frequent follow-up visits during the initial postoperative phase(s) after surgery. For the oversized condition issue, surgeons are advised that tightening the set screws to the prescribed tightening torque (80in-lbs) should fully mitigate the possibility of an adverse screw body splay event.
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
Brainlab has identified an issue where there is the possibility of a potential inaccurate dose calculation for small mlc-shaped fields when using the pencil beam algorithm. the pencil beam algorithm refers to beam data which is acquired by performing dose measurements for mlc fields at predefined field sizes and which are stored using the iplan rt physics administration / brainscan beam profile editor. due to an inaccurate implementation in the brainlab radiation treatment planning software, the interpolation between two measured values is less accurate a) the smaller the field and;b) the further away the equivalent field size is from the measured value. for certain treatment setups, this leads to the effect that an insufficient amount of monitor units (mu) is calculated and that consequently the delivered dose is lower than the planned dose. for clarity, the delivered dose does not exceed the planned dose due to the described issue.
Acción
As a workaround, to reduce the described dose deviation to less than 2% using the Pencil Beam algorithm in iPlan RT 4.5.x Brainlab recommends to modify the machine profile following the instructions outlined in the Appendix provided.
For all Brainlab treatment planning systems, as recommended by Brainlab, perform proper pre-treatment quality assurance for every treatment plan. Independent calculation of the dose using 3rd party QA Software or dose measurements inside a phantom is suitable to judge the accuracy of the dose calculation. Refer to the Brainlab Physics Technical Reference Guide for details.
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
Randox confirms a transcription error when quoting the concentration in g/l for glucose standard lot 2082gl. the correct value should state 0.98g/l.The risk to health when this issue occurs is the potential for reporting incorrect elevated glucose results. however this is highly unlikely as quality control results would also be elevated by a factor of ten.
Acción
Randox is requesting users;
1. Replace the kit IFU with the correct revision as attached to the customer letter;
2. Discuss the contents of the notice with your Medical Director; and
3. Complete and return the vigilance response form provided.
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
Medtronic is recalling specific item codes and production lots of the covidien nellcor rs10 spo2 forehead sensor. this recall is being conducted due to a labelling error. the label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. the sensor array itself is latex free. the use of products containing latex may result in allergic reactions for patients and providers who have latex sensitivity. allergic reactions can include skin rash, itching, dyspnoea and anaphylaxis. there have been no reports of serious injury associated with this issue.
Acción
Medtronic is advising users to quarantine and discontinue use of the affected item codes and lots. Also, immediately advise all surgeons/surgery personnel of this recall. Medtronic will be issuing credit for returned devices.
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 expiration date on the label for the referenced products is incorrect. existing testing supports an expiration date of 2 years from manufacturing. the affected products on the market were labelled with an expiration date of 10 years. there is biocompatibility test data to support an expiration date 2 years only.Use of this product beyond its expiry date of 2 years poses a theoretical risk of an adverse tissue reaction in the event the device develops cytotoxicity and/or infection.
Acción
Johnson & Johnson Medical (JJM) is requesting users Immediately inspect the device(s) in their possession to determine if your facility has affected product.
In the event defective product is identified please quarantine these units prior to returning them to JJM.
Return a copy of the completed acknowledgement form, even if no affected product is identified, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com
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 has received a field report noting that some units within a certain lot (00112758) were missing the bottom pouch seal that forms part of the sterile barrier. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. the compromised seal is completely missing and is obvious to the user. the device can be readily exchanged resulting in an insignificant prolongation in the medical procedure. to date there have been no reports of patient injury associated with a missing pouch seal.
Acción
Boston Scientific is advising customers to immediately discontinue use of and segregate product from the affected lot, and then return it to Boston Scientific. Credit will be issued for returned stock. This action has been closed-out on 28/06/2017.
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 healthcare diagnostics has determined that some lots of ammonia (amm) reagent used on both the dimension® and dimension vista® systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the instructions for use (ifu).
Acción
Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.