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.
Notes supplémentaires dans les données
Cause
Investigations into complaints received have shown that in rare cases, the tests mentioned may give either falsely low crp resultsor the measurement flow is interrupted by the error message “faulty reagent addition”. falsely low crp results, in general, may providemisleading information for the diagnosis, therapy and monitoring of inflammatory disorders.The reported issue in a worst case scenario may cause a delay in starting the antibiotic treatment.
Action
The sponsor is advising users to immediately quarantine and discontinue use of kits from the affected lots. This action has been closed out on 08 Jun 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.
Notes supplémentaires dans les données
Cause
A defective rotor yoke allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.If the rotor becomes unbalanced it may vibrate excessively and/or exhibit smoke if the rotor is rubbing inside the centrifuge.There is a chance of physical injury to users as a result of the vibration if the issue occurs. there is also a remote risk of a delay in results if the failure occurs.
Action
Beckman Coulter is replacing the affected rotor yokes. The centrifuge can continue to be used, as long as all runs are balanced appropriately.
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.
Notes supplémentaires dans les données
Cause
The ubc ii has a component which may fail prematurely due to a manufacturing defect. if the component fails, the charger’s firmware recognises the malfunction and prevents batteries from being charged. the blue led on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the user’s manual. when component failure occurs, the device firmware causes the ubc ii to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay.
Action
JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.
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.
Notes supplémentaires dans les données
Cause
Ge healthcare has recently become aware of a potential safety issue with the 3.0t gemflex coil manufactured by neocoil used with ge healthcare 3.0t scanners. part of the cable assembly may overheat when the device is used. there is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. so far there have been no injuries reported as a result of this issue.
Action
GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. 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.
Notes supplémentaires dans les données
Cause
Cardiac science has determined powerheart g3 defibrillation electrodes from lot no. 141125-02 may exhibit higher than expected electrical impedance over time. if electrode impedance becomes too high, the powerheart g3 automatic external defibrillator (aed) will fail the electrode self-test performed by the aed and it will not be rescue ready. specifically, if the aed fails the electrode self-test, the status indicator on the aed will be red and the aed will beep. this is standard behaviour when the impedance limit is exceeded. the aed will not be ready for use in a rescue in this state.The reported issue may result in failure to deliver shock therapy when needed and in the worst case could result in serious adverse health consequences, including injury or death. cardiac science is not aware of any instances in which lot no. 141125-02 electrodes failed to work at the time of therapy.
Action
The sponsor is advising users to identify the affected units and replace the electrodes with the replacement electrodes provided by the sponsor as per the instructions in the customer letter.
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.
Notes supplémentaires dans les données
Cause
Siemens healthcare diagnostics has confirmed that some packages of the berichrom antithrombin iii kit may contain a different substrate reagent lot as given in the package labelling. dependent on the instrument used, some instruments with automatic reagent identification may request a new calibration.The correct substrate reagent lot number is 520294. this issue has no impact on patient results.
Action
Siemens Healthcare is advising users that the affected product will be replaced with unaffected stock. This action has been closed-out on 03/02/2017.
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.
Notes supplémentaires dans les données
Cause
Siemens healthcare has confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. siemens’ internal investigation demonstrates:· an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42. · an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43. · the positive bias of lots ending in 42 to the master curve compared to the negative bias of lots ending in 43 to the master curve is the main driver for the negative bias between values generated with lots ending in 42 and 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the risk to health as a result of this issue is negligible. the biases observed across the assay range would not impact clinical management of patients being evaluated for androgen disorders or chemical castration.
Action
Siemens is advising users that Calibrator E with lots ending in 42 and 43 can continued to be used to calibrate Testosterone on the Centaur CP system. Lots ending in 44 and above should be used for other Centaur systems.
A review of previously generated results due to this issue is at the discretion of 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.
Notes supplémentaires dans les données
Cause
Ck surgitech has been notified of an incident concerning one of the above products. the device proved hard to fire, and upon deployment, detached a 10cm piece of wire that was removed through the scope with biopsy forceps. there is a risk of tissue puncture as a result of the issue.As a result, ck surgitech is recalling both the standard sureclip and the sureclip plus until investigations have been undertaken.
Action
CK Surgitech is advising users to inspect stock and quarantine affected units. Affected stock will be replaced or an alternative product supplied.
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.
Notes supplémentaires dans les données
Cause
A software bug has been reported that when using certain roi (region of interest) editing tools, if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. in order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the roi. saving of an unintended state may lead to ineffective and/or unintended radiation therapy. the patient views and the beam’s eye view will always be displayed correctly in the plan approval dialog and in the plan reports. closing and reloading a case will always generate correct views. dose is always computed based on the stored system state.
Action
This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to:
-Always release the left mouse button before using other keys or mouse buttons.
-If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017.
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.
Notes supplémentaires dans les données
Cause
There is a chance that the connection between the tube and the tip is faulty. this can lead to the tip loosening during use. the resulting risk for the patient, is that the tip could be left behind in the treated area or could be inhaled, which may lead to a severe health impairment for the patient. to date we are not aware of such a case.
Action
CoreMed is advising users to quarantine any remaining stocks of the affected product and return 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.
Notes supplémentaires dans les données
Cause
This recall is initiated due to incorrect information provided on the labelling. in the course of routine quality tests, it was discovered that sangofix sets with hand pump contain dehp (approx. 1.6% per set). the sangofix sets, however, are labelled dehp-free.The mislabelling is limited to the affected article numbers as the dehp containing hand-pumps are only used in the specified products.
Action
B. Braun is advising users to inspect stock and quarantine all units with the affected article codes. Affected stock can be returned to B. Braun and users will be issued a credit note. 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.
Notes supplémentaires dans les données
Cause
The terumo cdi h/s cuvette is included in some cardiopulmonary bypass packs supplied by lovell surgical supplies international.Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the “h/s disconnect at cuvette” error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display. if failure of the cdi h/s cuvette connection is recognised after initiation of cardiopulmonary bypass (cpb), the clinician will have to choose between changing out the cuvette (which requires the interruption of cpb for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend haematocrit/saturation (h/sat) values.
Action
Lovell Surgical Supplies is providing users additional instructions to check the cuvette is properly connected before use. Thia action has been closed-out on 19/01/2016.
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.
Notes supplémentaires dans les données
Cause
A software issue has been identified in the medication management module which may lead to duplication of medication dose under specific settings. this can only occur when a medication order has a weekly interval (e.G., administer medication x every monday) and an attribute (e.G, dose quantity or frequency) of the order is subsequently modified.
Action
A temporary mitigation was provided by means of modifying the software configuration setting. Specifically, the proposal was to extend the time horizon from 7 days, which is equal to the dose interval, to greater than 7 days. A permanent solution will be provided once it becomes 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.
Notes supplémentaires dans les données
Cause
There have been reports overseas that sample tubes may not be correctly placed back in the rack tube transport (rtt) after the de-capping process. this may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. a false triggering or detection of the “ready” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. the system then continues with the next process step and opens the gripper prematurely. this issue may lead to contamination of the instrument and other samples. the risk to operator of contamination is less than remote. however, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment.
Action
Roche Diagnostics has developed a software patch (71829_p512) to correct the reported issue. The implementation of this software patch is mandatory and will be installed by a Roche Diagnostics Australia field service representative. Users are advised to monitor the system for the Error 140 “Missing Tube” until the software patch is installed. If this error code occurs, please clean all components in contact with the spillage (refer to Operator’s Manual v1.5). This action has been closed-out on 15/02/2017.
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.
Notes supplémentaires dans les données
Cause
The testing undertaken by the tga for the above batch of conceiveplease one step hcg urine pregnancy test has shown that this batch does not comply with the claim in the instructions for use which specify that "ln less than 5 minutes, levels of hcg as low as 25mlu/ml can be detected".Batch 20131203 failed to detect hcg in human urine at concentrations of 10 and 25miu/ml levels. false negative results in the worst case can result in misdiagnosis, which can have significant consequences. the tga is undertaking further investigations to ascertain if any further actions are required.
Action
Please note that ConceivePlease Pty Ltd has advised the TGA that only fewer than 100 kits from the affected batch were supplied to retailers during a three week period, from 21 January to 11 February 2016. Customers are advised to quarantine any unused stock from the affected batch and return them to the place of purchase for a refund. For more information please see http://www.tga.gov.au/alert/conceiveplease-one-step-hcg-urine-pregnancy-test . This action has been closed-out on 19/01/2017.
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.
Notes supplémentaires dans les données
Cause
Investigations have shown that after performing the suctioning manoeuvre, including disconnecting the patient, suctioning and reconnecting the patient, the present pattern of ventilation may not continue as expected due to a software issue. under certain conditions, a different ventilation mode than the operator selected mode may be applied. this situation can occur independent from the selected patient group (neonate, paediatric or adult). if the ventilator’s incorrect behaviour is not detected, the patient is ventilated with the ventilation mode active prior to the pre-oxygenation phase. in the worst case, the patient may be either hypo ventilated or hyperventilated.
Action
The sponsor Taleb is advising customers that a software update (v 2.60) will be installed on all affected units by June/July 2016. As an interim measure, the sponsor will permanently disable the automated suctioning manoeuvre functionality on all affected units. In addition, the operator must verify that the ventilation continues after a suctioning manoeuvre is finished. If the ventilation does not continue as expected, one of the following options can be used to re-establish ventilation as set:
• Press the “Manual Breath” key on the ventilator’s front panel.
• Select a different ventilation mode.
• Switch to the “Standby mode” and return to the previously used ventilation mode. This action has been closed-out on 09/05/2017.
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.
Notes supplémentaires dans les données
Cause
Since the introduction of a fix to the measurements algorithm (bz55214), inteleviewer now uses the ratio of the distance from the source to patient over distance from source to detector to compute a scaling factor to apply to measurements when the estimated radiographic magnification factor (dicom (0018,1114)) is not present. that scaling should only be applied when dealing with a projection radiography modality (cr, dx, mg, px, rf, or xa), however, it ended up being applied to other modalities, such as ct, generating erroneous measurements.This software defect could lead radiologists to base their diagnosis/report on wrong anatomical measurements. no patient incidents have been reported at this time.
Action
Emergo is advising users to ensure that they uninstall the affected software version from their workstations and install an alternative version of lnteleViewer (e.g. IV 4-11-1 P143 or IV 4-11-1 P145). Also, users are advised to review the studies that were done with lnteleViewer 4-11-1 Pl44 and determine appropriate follow-up with patients. Users will be provided with the list of potentially affected studies.
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.
Notes supplémentaires dans les données
Cause
A manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (vesa 75/ 100 adaptation with rotation). the riveting of the rotation may not have been carried out according to the manufacturer's specifications.In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users.
Action
KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site.
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.
Notes supplémentaires dans les données
Cause
Ortho-clinical diagnostics (ortho) has identified an anomaly in ortho vision analyser software that may occur when either:1. an ocd field engineer performs a clean-up of the analyser database, or an operator of the vision analyser restores a database backup on the analyser, and 2. dilution trays have not been removed from the instrument prior to restarting the system.In this scenario, the analyser software cannot identify usage history of the wells of the dilution tray on the instrument, and reuse of wells may occur.For tests that involve dilution of patient red blood cells, the reuse of a dilution well can potentially lead to false positive or false negative results. to date, only false positive results have been observed during internal testing. there is a risk of false positive or false negative anti-d testing, which may result in haemolytic transfusion reaction. no customer complaints or patient injuries have been reported due to this issue.
Action
Ortho Clinical is reminding users to ensure the dilution wells are removed and disposed of prior to initiating a database restore operation. This issue will be addressed in a future version of the software and a Technical Bulletin issued to remind users to remove and dispose of dilution wells prior to restoring a database. This action has been closed-out on 20/02/2017.
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.
Notes supplémentaires dans les données
Cause
Medtronic has identified that due to the sensitivity of an algorithm used in the reveal linq icm, the recommended replacement time (rrt) alert may be prematurely triggered in some devices. the rrt alert is an indicator for when the reveal linq device should be replaced, therefore the premature alarm indicates replacement before it is necessary. this matter does not impact the ability for the reveal linq device to safely continue collecting data. manual data transmissions may also still continue. device battery capacity is not affected. medtronic has not received any reports of patient complications or injury related to this issue. medtronic has observed an occurrence rate of 0.45% of devices experiencing this issue.
Action
Medtronic is advising clinicians that prophylactic device replacement is not recommended unless the clinician determines the loss of daily wireless transmissions outweighs the potential complications associated with device replacement. If a premature RRT alert is confirmed and EOS status is displayed, options to continue ongoing monitoring include remote manual transmissions or performing an interrogation of the programmer. Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor.
Thia action has been closed out on 08 Jun 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.
Notes supplémentaires dans les données
Cause
The arrow intra-aortic balloon catheter and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the manufacturer has advised there is the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of iab therapy can occur.
Action
The sponsor is advising customers to immediately quarantine all affected kits. The sponsor will deliver replacement kits to the affected customers before the recovery of the affected kit. In the case of an emergency situation before the replacement kit can be delivered, the sponsor is advising that the Arrow IntraAortic Balloon Catheter can be inserted through the following alternative 8 Fr. sheaths:
-St Jude Medical Diag Maximum
-Terumo Pinnacle
-Cordis Avanti . 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.
Notes supplémentaires dans les données
Cause
An investigation has identified that verso shoulder forked retractor part number 402582 was manufactured using 420 stainless instead of 420 s29 stainless steel. 420 stainless steel is more brittle than 420 s29. the instrument may fracture during use. if the retractor fractures during surgery, surgical intervention may be necessary to retrieve any fractured pieces. a delay in surgery greater than 30 minutes may occur. if the pieces are unable to be retrieved, the patient would retain a foreign body.
Action
The sponsor is advising users to inspect stocks and quarantine the affected units. The sponsor will remove and replace the affected units. This action has been closed-out on 25/01/2017.
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.
Notes supplémentaires dans les données
Cause
The manufacturer has identified that during printing an operator error occurred where the foil used as the primary packaging for coban 2 lite shows "coban 2" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for coban 2 lite) is correct. if coban 2 lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. this would be noticed by the health care provider and corrected with the next bandage change.
Action
3M Australia is advising users to inspect stock and quarantine any affected product for return or credit.
This action has been closed-out on 30/01/2017.
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.
Notes supplémentaires dans les données
Cause
The manufacturer has advised that during printing an operator error occurred where the foil used as the primary packaging for coban 2 shows "coban 2 lite" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for coban 2) are correct. if coban 2 is used (rather than coban 2 lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. this could lead to local necrosis or complete ischemia of the lower leg.
Action
3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.