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 failure in the sterile peel pouch has been discovered during a quality control inspection by the manufacturer, asc. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. a comprehensive investigation has identified an occurrence rate of less than 0.01% for the affected lots.
Acción
LifeHealthcare is advising users to inspect stock and quarantine any remaining product for return. 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.
Notas adicionales en la data
Causa
It has been identified that the affected lot of aquasil easy mix putty may exhibit setting characteristics which are not normal for this product. the affected products may exhibit an extended set time. there is no risk to patients.
Acción
Dentsply is advising users to return any remaining unaffected stock. This action has been closed-out on 16/02/2017.
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.
Notas adicionales en la data
Causa
Following customer complaints, bio-rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. bio-rad is recalling the lots identified. this recall is being conducted as a precautionary measure.A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion.
Acción
Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. 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.
Notas adicionales en la data
Causa
Smith & nephew is issuing an update to a medical device hazard alert issued in 2015 to provide surgeons and hospitals with updated information on the birmingham hip resurfacing (‘bhr’) product range and the birmingham hip modular head (bhmh) system. this update contains a current summary of the information concerning the revision rates of various products in the bhr and bhmh systems (including the monoblock version of the bhmh system).
Acción
The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has been closed-out on 24/05/2017.
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
The manufacturer, iris international has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes.
Acción
Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material.
Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. 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.
Notas adicionales en la data
Causa
The manufacturer, corinthian surgical ltd has been made aware of a cluster of cases in the united kingdom where it has been observed that there has been some bone re- absorption in the area adjacent to the granules in the middle ear. this can lead to exposure of the dura and facial nerve, potentially resulting in infection and/or brain herniation. as a precautionary measure corinthian surgical ltd is temporally suspending the supply of serenocem granules and there should be no further use of the granules at this time. the cause of the reported cases of bone resorption is currently under investigation.
Acción
Endotherapeutics is recommending that if a patient presents for a routine checkup or at the 2 yearly follow up, to perform a CT scan. Outside of these circumstances, patients should undergo a CT scan at the clinical discretion of the treating surgeon. Any remaining unused stock should be quarantined and returned to Endotherapeutics. The investigation is currently ongoing, and further communications may be required following completion of the investigation and in consultation with the Therapeutic Goods Administration (TGA).
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’s (bsc) review of the post-market data has identified an increase in the number of complaints related to ‘catheter release pin mandrel break’. the failure can occur during sheathing as part of device preparation or re-sheathing during the procedure, if repositioning is required. the release mandrel break is most commonly identified during the valve releasing phase of the procedure. in the event of a broken release mandrel, the physician will re-sheath the valve and replace the device. in addition to the 24 complaints reported during nov 2014 – jan 2016, there were 8 complaints reported in february 2016 related to release mandrel. there has been one complaint event reported in february 2016 which resulted in a patient death. bsc’s investigation concluded that incorrect preparation of a device may contribute to increased opportunity for the release mandrel to break.
Acción
Boston Scientific (BSC) is initiating this action to:
1- Provide additional clarification on the instructions for preparing the Lotus Valve System prior to the procedure; and
2- Ensure all certified physicians have received all training necessary for independent implantation of the device, i.e., without the support of a BSC Field Clinical Specialist (FCS).
Boston Scientific is advising users that the relevant training manuals have been updated to avoid crimping the mid-section of the valve during sheathing. Boston Scientific Field Clinical Specialist will re-train all cath-lab staff in the revised procedures. Users in "Non Independent" sites are reminded to ensure all procedures are completed with the support of a Boston Scientific Field Clinical Specialist until the site has been designated to be "Independent" by Boston Scientific. This action has been closed-out on 30/01/2017.
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
The analysis of a customer complaint has identified an issue related to suctioning with the use of the hamilton-g5 and hamil ton-s1 ventilators. after performing the suctioning manoeuvre, including disconnecting the patient, suctioning, and then reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator selected mode maybe applied; this situation can occur independent from the selected patient group (neonate, paediatric, or adult). this situation may occur if the ventilation mode changes during the pre-oxygenation phase. after the suctioning manoeuvre is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. in the worst case, the patient may be either hypo ventilated or hyperventilated.
Acción
AHC is providing instructions to deactivate the suctioning option on all affected ventilators until a software upgrade to version 2.60 has been installed. Users are advised to ensure there are alternative suction devices 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
The fasteners securing the control panel assembly to the base of the philips epiq ultrasound system may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.If the control panel assembly detaches from the ultrasound system and falls, bruising of the operator or other minor injury could result.
Acción
Philips will contact all EPIQ customers to arrange for service to replace the fasteners connecting the control panel assembly to the system with fasteners less likely to loosen with repeated handling. This service will be performed free of charge.
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
Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. there is a risk the monitor could fall and swing freely on the swing arm and strike a person or object. there have been no reports of injuries as a result of this issue.
Acción
Trumpf Medical is advising users that if the systems are due for biennial maintenance, to contact the authorised service provider to schedule the preventative maintenance.
If the biennial maintenance is not due, and the service provider did not inspect the welds during the previous maintenance, contact the service provider to schedule a service call to inspect the welds.
Requirements to inspect the welds during biennial maintenance can be found in the User Manual.
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
Issues have been identified regarding the video display cables, video display assembly (internal pc board) and the pneumatic assembly for certain cardiosave hybrid and rescue iabps.1 - the cardiosave iabp may have intermittent connectivity issues with the video display cables causing display blanking followed by a “system failure” audible alarm and shut down.2 - the cardiosave iabp video display assembly may shutdown during operation due to a short on the video generator board.3 - intermittent connection with the cardiosave pneumatic module connector resulting in iabp startup failure and/or iabp shutdown.To date, there has been no reported patient harm or adverse events attributable to these issues.
Acción
Maquet is advising users to ensure an alternative device is available at all times as a backup, and that the affected units should not be used during ground or air transport. Maquet will be performing an on-site service to correct the reported issues. This action has been closed-out on 23/01/2017.
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
The service procedure describing replacement of a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could be over-torqued if the component is replaced on your system. in the unlikely event that the bolts fail on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no reports of this issue.
Acción
GE has updated the Service Manuals for the affected products to update an incorrect torque value and is advising users to ensure the organisation that services the affected equipment uses the latest version of the Service Manual. The latest version of the Service Manuals can be downloaded from the GE document library. 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.
Notas adicionales en la data
Causa
It is possible to have incorrect label information displayed when viewing multiple hamamatsu .Ndpi (brightfield) and .Ndpis (fluorescent) images with imagescope software. slides which do not use the .Ndpi file format are not affected. the correct labelling information is presented in the patient's case in eslide manager.This is an isolated issue that may only be experienced by customers who meet all of the following criteria: - use aperio eslide manager release 12.2.1 or newer including version 12.3 - use hamamatsu .Ndpi (brightfield) or .Ndpis (fluorescent) image format - open multiple images exceeding the local server cache memory no patient injury or adverse events have been reported. however, there is a potential for a delay in diagnosis, failure to diagnose or an incorrect diagnosis.
Acción
Leica Biosystems is advising users to discontinue use of Hamamatsu .ndpi and ndpis image formats with ImageScope viewing software, until a software correction can be performed. Leica is recommending users review cases containing the affected image formats to ensure patient label information is correct. This action has been closed out on 14 June 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 identified that the ph parameter may recover low within range or lower than expected with the affected lots of level 3 rapidqc complete product on both the rapidpoint and the rapidlab blood gas systems. the issue identified represents a negligible risk to patients and does not pose any health or safety risk to operators.
Acción
Siemens is advising users that if the QC values are recovering within range, the lots can continue to be used. If the affected lots are not recovering within range, the lots will be replaced with unaffected stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips received reports from the field that certain ingenuity core systems running software version 3.5.4 exhibited intermittent swirl-like ring artefacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. a patient rescan may be required due to impairment of the diagnostic quality of the reconstructed images.
Acción
There are no proactive actions for the user. Clinical judgment should be used by the clinician to determine if the images contained in the dataset without artefacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a rescan of the patient may be required. Philips Healthcare is implementing software update version 3.5.5 to correct the above-described issue. This action has been closed-out on 30/01/2017.
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
Roche diagnostics has tested for fulvestrant interference / cross-reactivity with the elecsys estradiol assay; this investigation has shown that fulvestrant could potentially affect patient sample results. the reported issue may lead to falsely elevated results of estradiol. subsequently, misinterpretation of the hormone status could occur and the use of fulvestrant may be altered. in addition, the efficiency of anti-estrogen treatment might be underestimated.
Acción
Roche is advising customers that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. A review of estradiol assay results in patients taking fulvestrant is recommended. A disclaimer will be added to the “Interference – Limitations” section in the Method Sheet of the Elecsys Estradiol III assay: This action has been closed-out on 30/01/2017.
“Due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with Fulvestrant.”
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Cook medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. the preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporised hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. it is recognised that there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolisation to the heart or lungs, or occluding blood flow to end organs.
Acción
Cook Medical is advising users to quarantine and return any unused product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The pivot cinchlock ss knotless anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.Several complaints have been received relating to the pull wire breaking. there are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.The broken pull wire may spring out of the inserter handle that may injure the user. inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure.
Acción
Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 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
Covidien respiratory and monitoring solutions, now a part of medtronic, is issuing a recall for the battery pack used in oridion labelled capnostream20p patient monitors. the scope of this recall includes battery packs that were manufactured between april 2014 and february 2016. the recall includes battery packs included with the monitors and spare replacement parts purchased separate from the monitor. this recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack. there has been one report involving a fire resulting in smoke inhalation and minor burns to a user.
Acción
Medtronic is advising users to identify, remove and appropriately dispose of affected battery packs using the instructions provided. Alternatively, contact Medtronic with assistance with the disposal.
Once the batteries are removed, the Patient Monitor must be connected to AC power and can no longer be used for intra-hospital transport of patients until replacement batteries are provided. This action has been closed-out on 28/02/2017.
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.
Notas adicionales en la data
Causa
The bpm sensor head assembly’s thermistor, which provides the blood temperature value does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values. the thermistor measurement takes longer to reach actual temperature and temperature measurements at the extremes (18°c and 37°c) are the most inaccurate. lowest temperature displayed was about 19°c for the thermistor when a different thermistor measured the temperature near 15°c. highest temperature displayed was about 32°c when a different thermistor measured about 37°c. inaccurate temperature measurement could also cause inaccurate measurements of other bpm values including potassium (k+), po2, pco2, and ph. the algorithms for these parameters rely on temperature for the calculations. inaccurate measurement of these values could result in inappropriate patient management. there have been no reports of injury.
Acción
Terumo is advising users they can either;
- Stop using the affected devices and return them to Terumo for repair. A loan unit will be provided until the corrected devices can be returned, OR
- Continue to use the affected devices only for HSTAT monitoring functions until the replacement parts are available. These functions are unaffected by the issue. Once the replacement sensor heads are available, the devices should be returned to Terumo for repair. This action has been closed-out on 10/05/2017.
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
The manufacturer, biosense webster, is clarifying the contraindication language in the instructions for use (ifu) and product labelling for use of this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: “[the] use of this catheter may not be appropriate for use in patients with prosthetic valves.” the update to the ifu is to clarify the contraindication statement to the following: “do not use pentaray catheters in patients with prosthetic valves”.If excessive force is applied on the entangled catheter spine, there is a potential for parts to detach and embolise inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. the likelihood of these serious complications remains low.
Acción
Johnson and Johnson Medical (JJM) are providing users with an updated IFU to follow to ensure the products are not used in patients with prosthetic valves. This action has been closed-out on 10/05/2017.
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
Bard peripheral vascular (bpv) has confirmed that the affected lot numbers may be at risk of having an incorrect sample trap assembly. a portion of the affected lots may contain units with incorrect sample trap assemblies affixed to the probe inside the product tray (a lateral assembly instead of an upright assembly). the labelling on the outer product carton and inside packaging tray is correct. specifically, the issue is that the incorrect sample trap assembly contains shorter vacuum tubing and no clear tray cover.The potential harm associated with attempting to use this device labelled for upright use may result in the sample trap assembly being filled with fluid during use and when removing the sample collection tray (basket), the sample(s) may fall out of the collection tray because of the lack of a cover.
Acción
Bard is advising users to inspect the affected lots before use to ensure the correct trap assembly is affixed to the probe. This action has been closed-out on 30/01/2017.