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) received reports of positively biased crp results using vitros crp slides when diluting samples. investigation undertaken by ortho identified that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the magnitude of bias increases as the dilution factor increases.
Acción
Users are advised to follow the instructions in the customer letter to perform dilutions when processing samples above the measuring range for CRP. VITROS CRP Slides Instructions for Use (IFUs) will be revised to include the additional instructions to follow when diluting samples with results above the measuring range. Discuss any concerns regarding previously reported CRP results with the Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. This action has been closed-out on 26/05/2017.
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
Medtronic was recently notified that the manufacturer, oscor has initiated a product recall for certain lots of their adelante breezeway 8f & 10f sheaths due to a potential for "a fragment of the sheath inner liner to come off during the insertion of the dilator during the preparation of the sheath prior to use." medtronic sells the oscor adelante breezeway 10f product as the arrive braided transseptal sheath. oscor has received one complaint related to this issue, which did not result in patient injury. however, the risk for possible injury is a concern if the sheath is not properly flushed and tested with the dilator prior to use.
Acción
Customers are advised to immediately quarantine and return all affected stock. Medtronic Customer Service Representative will organise the return and replacement of unused products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with the standard patient management protocol.
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 small light marker window used for the positioning laser and integrated in the front cover of the ct that had loosened in the past and had been subsequently fixed, could now become loose again and potentially drop out. in this case, there is a risk that a person could touch rotating or electrical parts of the gantry when reaching through the window opening. there is a risk for serious injury e.G. by electrical shock or physical harm to fingers.
Acción
Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.
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 during the validation verification of the sterilisation procedures. there is a risk in connection to sterilisation conformity for specific batches. this could lead to an increased risk of infection in the days following surgery. no adverse event has been reported worldwide in relation to this issue.
Acción
Life Healthcare is advising surgeons to review their patients who have been implanted with the affected products for any post-operative infection.
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 problem has been detected in the transperineal stepper with stand. the stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms.
Acción
Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017.
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 incorrect current rating label has been applied to the rear side of the imr (single computer) host cabinet (4598-004-44981).The non-conforming label states the current rating as 4.8a (instead of 2.4a), as defined in the host rack imr specifications. the correct label on the host imr rack should have electrical rating values of: 230v — 2.4a, 50/60 hz.
Acción
Philips Healthcare is notifying the affected users of those issues via this letter. A Philips Field Service Engineer will contact those users to schedule the Rack/Cabinet label re-work on-site. Reference Field Change Order (FCO) 72800667. This action has been closed-out on 23/06/2017.
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
In the postoperative course patients reported a temporary or permanent development of noise. concerned were approx. 0.12 % of the disc prostheses. in some individual cases the doctors in charge decided to remove the implant. extensive analyses by the manufacturer, signus medizintechnik has not identified any indications as to the causes of the noise development as yet. examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear.
Acción
The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).
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
This communication is an update to medtronic’s march 2014 notification regarding the potential for synchromed ii pump over-infusion. “over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents that are less than expected may indicate that the pump has over-infused. over-infusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. the low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir.
Acción
Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump . This action has been closed-out on 26/05/2017.
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 telemetry spo2 numerics dropping off the xhibit central display when using software version 1.1.5 with connectivity to telemetry. desaturation, high, and low limit alarms work normally. this problem can occur when the xhibit central station software version 1.1.5 is used in conjunction with a telemetry receiver for purposes of remote patient monitoring.Ecomed pty ltd has not supplied any telemetry receiver medical devices to the australian hospitals that are connected to software version 1.1.5 of xhibit central station.
Acción
Although there is no product affected in Australia, product correction is being undertaken by Ecomed Pty Ltd to support potential future use of telemetry functionality with the Xhibit Central System in relevant Australian hospitals. Ecomed will be contacting affected customers to perform a software update. This action has been closed-out 11/05/2017.
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
There have been customer reports of the valleylab laparoscopic handset continuing to operate after release of the activation button. if the device continues to operate after deactivation by the user, it can increase the potential for internal tissue burn or damage. at this stage, 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 products and to inform all surgeons and surgery personnel of this issue. Users are further requested to label affected stock prior to their return to Medtronic 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
St jude medical (sjm) has identified that patients with nanostim leadless cardiac pacemakers may experience loss of telemetry and pacing due to battery malfunction. investigation by sjm found decreased battery capacity due to reduced electrolyte, resulting in high internal battery resistance. this disrupts the required capacity for proper device function and reduces device longevity. there have been seven (7) reports worldwide of lost telemetry and pacing output as a result of a battery malfunction. battery malfunction may be indicated with a loss of telemetry/communication with the implanted device and/or loss of pacing and magnet mode operation. these events occurred between 29 and 37 months post implant. no patient injuries have been reported in association with the loss of bradycardia pacing therapy.
Acción
St Jude Medical has contacted the cardiologists who have implanted Nanostim leadless cardiac pacemakers providing further information about the above issue including patient management recommendations. They have been instructed to stop implanting these devices into new patients. For more information, please refer to https://www.tga.gov.au/alert/nanostim-leadless-cardiac-pacemaker . This action has been closed-out on 15/05/2017
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
Customers with software version va50_sp2 will be provided an update to software version va50_sp3. the installation of this update will address software bugs that were identified through field monitoring. some of the major bug fixes that will be addressed with this software are:1) correction to volumetric misrepresentations of high contrast objects when using admire.2) correction to highly sporadic scan aborts due to temporarily tube currents at 0ma.3) correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4) correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.5) correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.6) correction to highly sporadic scan aborts due to temporarily high disk load of system disk.7) correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing.
Acción
Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite.
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
This recall has been initiated as a precautionary measure based on internal testing that simulated normal product use. there have been occasional occurrences where the residual peroxide remaining in the lens case after neutralisation was above product specification. this could lead to the user experiencing temporary ocular symptoms such as burning/stinging, irritation, and red eye.
Acción
Pharmacists and optometrists are advised to quarantine affected stock and to return them to the place of purchase for a credit. They are also advised that should a consumer return any stock affected by this issue; please offer them a full refund. Wholesalers are advised to immediately quarantine and destroy all affected/returned 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
Stryker has received reports of two potential issues related to the offset cup reamer handle. the weld on the u-joint of the handle may become damaged over time, potentially causing the pin or pieces of the pin to fall into the wound. if that occurs, and the surgery proceeds with reaming, the pin or pieces of the pin may fall into the wound, which may be removed if visible or may be left in the wound. the handle also may not fully engage with the registration array and/or reamer basket. if that occurs, the surgery may proceed using a backup offset reamer handle, a straight reamer handle or manual instrumentation.
Acción
Customers are advised to inspect their inventory for affected product and quarantine it immediately. A Stryker representative will coordinate the return of any affected products. This action has been closed-out on 28/06/2017.
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
Through a review of packaging, stryker has identified that the seal integrity of the pouch may be compromised. more specifically, there is a potential that the sterile pouch may not be sealed at one end due to a manufacturing error. a missing seal could potentially lead to unsterile product. risk mitigating factors include that the non-conformance is obvious to the user. surgical guidelines outline inspection of the sterile barrier (seal) for sterile packed medical devices prior to use. the pouch itself shows a note: “contents sterile unless this package has been damaged or opened.” the secondary packaging is a (plastic) clear tube with silicone caps at both ends. while not validated as a sterile barrier, it does provide additional protection to the enclosed pouch package configuration. no injury or harm has been reported regarding this issue.
Acción
Customers are asked to inspect their inventory for affected products and quarantine any affected items immediately. A Stryker representative will coordinate the return of any affected product and supply unaffected ones where necessary. 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
The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans, due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected, there have been 2 occurrences of this failure mode in the past 10 years. this issue could result in undesired radiation due to multiple exposures of the same anatomical region caused by failed couch motion during ct scanning.
Acción
A Philips Field Service Engineer will contact affected customers to schedule the updates. In the interim, customers are advised to follow the warning in the Instruction for Use: “During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.”
If the patient table is not moving when it is commanded to move during CT scan, abort the scan by pressing the Pause button or Emergency stop actuator and call the local Philips representative.
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 axiom artis systems with software version vb35e and megalix x-ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci "small" and "micro" (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.
Acción
A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end.
Users are advised that:
- For system operation with a 2-foci Megalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program.
- For system operation with a 2-foci Megalix X-Ray tube, It is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program.
- There should be standard emergency procedures in place in case of system failures.
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 artis systems with software version vd11, and gigalix x-ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci “small” and “micro” (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.
Acción
A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end.
Users are advised that:
- For system operation with a 2-foci Gigalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program.
- For system operation with a 3-foci Gigalix X-Ray tube, fluoroscopy is still possible with the "small" or "micro" focus that is still intact through manual selection of a corresponding fluoro program. In addition, image acquisition with the large focus is still possible.
- There should be standard emergency procedures in place in case of system failures.
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
Testing by the tga has found that supergloves vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
Acción
Supergloves Australia Pty Ltd is advising all customers & distributors to quarantine all Supergloves Vinyl Examination Gloves with ARTG # 196064 printed on the box and to contact Supergloves who will arrange for the stocks to be recovered and a credit note issued. This action has been closed-out on 23/05/2017.
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
Physio-control has become aware that the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value when using etco2 in the kpa or % setting mode and in a situation where the reading is above 9.9 kpa. although only part of the first digit of the etco2 value is obscured by the respiratory rate, the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient’s etco2 value. clinical misinterpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment and/or delays in clinical decision making. there have been no reports of incorrect patient treatment or harm associated with this issue.
Acción
Physio-Control is requesting users to:-
1. Forward this information to all associated sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator;
2. In the event staff use LIFEPAK 15 monitor/defibrillator to display EtCO2 values they should also display the EtCO2 waveform which includes the range along the right side of the display;
3. In the event staff use either kPa or % settings, they should activate EtCO2 alarms to identify EtCO2 values outside the normal range; and
4. If local protocols allow this option, consider changing the EtCO2 to measure in the mmHg setting.
Once a permanent correction is developed Physio-Control will post information on our website when an updated software version is available.
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
Cepheid has received reports that some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types. as in all xpert assays, when the test is determined to be invalid due to a failure of a cartridge or instrument quality check, no patient results are reported and the report designation is “invalid.”.
Acción
Cepheid is advising customers to stop using the affected lot and dispose of any remaining product of this lot in their inventory. Cepheid will provide replacement product. This action has been closed-out on 18/05/2017.
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
Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm. if the ct data contain slices that occur at positions of xx.X50mm, there can be portions of the volume where there is a mismatch between the contour graphics shown on the screen and the contour data used during the optimisation and calculation of dose. unloading and reloading the patient data corrects the problem.Incorrect structure volumes can be used during optimisation. incorrect electron densities can be assigned to some regions of the patient.This can result in incorrect dose calculations. dose errors of greater than 5% can occur.
Acción
This problem will be resolved in Monaco release 5.30 and in patches to Monaco releases 5.10 and 5.11. In the interim, the problem can be avoided if the user takes the following action:
- Following contour edits, perform an “Unload All” and reload the plan prior to performing dose calculation. This action has been closed-out on 26/05/2017.
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
Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is the potential for infection to occur.
Acción
Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.
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
It has been found that the locking function may fail under certain conditions. the activation locking can only be activated by the clinician prior to the fitting of the device. the units that have been supplied in australia do not have the locking mechanism activated. please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. however, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated.
Acción
Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.