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
Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming ez1 dsp virus reagent cartridge lot (reg cart virus lot160011000). in the affected reagent cartridges, the proteinase k solution in well 10 is missing, i.E. well 10 is empty. at a maximum, eight of the 48 reagent cartridges in one kit are affected. all affected reagent cartridges are on position 6 within the clamshell box.
Acción
Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen technical service to arrange replacement.
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 is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm (1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
Acción
Thermo Fisher are advising users to inspect stock and quarantine all unused units from lot 20180120. Thermo Fisher will arrange recovery and replacement of impacted stock.
Correctly labelled product will be available in the next 3-4 weeks.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
During a dbs lead implant procedure, the fhc depth stop adapter is placed onto the lead to set the desired distance to target. the depth stop adapter then mounts in the lead measurement fixture to ensure that the lead is not inserted beyond the targeted depth. the fhc depth stop adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. this damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure. recent reports of lead short circuit events have led to an improvement of the depth stop design and a recall the previous version of this product. to date, there have been no reports of patient death related to this problem.
Acción
Emergo is advising FHC and Medtronic Field Representatives will review user's inventory and replace affected Depth Stop Adapters on hand with an improved design.
In the interim, Emergo advise that users do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Emergo Australia, or their local field rep.
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 is advising of a potential issue with artis pheno systems. during manual rotation of the c-arm at maximum speed, the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the rotation and can drop up to 40 mm {1.6 "). this can happen during an ongoing procedure. if this problem occurs, the system performs a safety stop. the system can then be operated normally again. under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop.
Acción
As an immediate measure, Siemens' service organisation limits the maximum manual LAO/ RAO rotation from 25°/sec to 20°/sec and Cran/Caud rotation from 20°/sec to 10°/sec. All other system parameters as well as 3D acquisition and Perivis ion/Peristepping remain unaffected.
Siemens are working on a solution to restore the system back to the original settings, and their service organisation will contact affected users to arrange an appointment to carry out the corrective action.
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
Further to the safety alert communication of april 24th 2018 (rc-2018-rn-00337-1), abbott is now advising of the firmware update availability.As part of a planned series of system updates that began in 2017 with the release of merlin@home v8.2.2 software, a firmware update has been developed with the intention to further strengthen the security and improve the performance of high voltage implantable cardiac devices (icds and crt-ds). the firmware upgrade is recommended for all eligible patients and includes the following updates:1. a battery performance alert update to provide further detection capability for premature battery depletion in certain high voltage devices (i.E. battery advisory devices), and2. a cybersecurity update to provide an additional layer of protection against unauthorised device access.
Acción
The software upgrade indicated in the previous communication RC-2018-RN-00337-1 will be available in the first week of June 2018.
Abbott is contacting doctors (physicians) to provide details regarding risk and patient management recommendations. Surgeons should consider the information in the letter and their patient's circumstances in deciding whether to update the firmware in implanted devices.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Baxter healthcare has identified an issue with the use of an incorrect plastic formulation in the manufacture of the blue luer component of the floseal malleable tips. the plastic formulation does not present any toxicity or biocompatibility concerns, but does impact the physical characteristics of the blue luer component. the affected lots of the floseal malleable applicator tip have been associated with the cracking of the luer upon connection with the syringe. since the tip is attached to the syringe outside of the surgical field, it is unlikely that plastic fragments would reach the surgical field. nevertheless, in exceptional cases, detached subvisible particles may be retained in the body and may cause inflammation, or serve as a nidus for bacteria in already contaminated wounds and contribute to allergic reactions. to date, there have been no reports of serious injury associated with this issue.
Acción
Baxter is advising customers to locate and return all units of the affected product. Instructions for return can be found on 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.
Notas adicionales en la data
Causa
Two issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
Acción
Samsung is advising users:
1. Carefully close the detector tray and check that the detector tray is completely closed.
2. When using a portable detector:
a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or
b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas.
3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12).
If the intended detector is not set, please select the detector to be used.
Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.
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 has identified that the irrigation pin used to manufacture (moulding) the hub outer tube was incorrectly placed in the mould. the use of a shorter pin resulted in blockage of the irrigation lumen of specific straightshot microdebrider blades.To date, there have been no reported injuries as a result of this issue.
Acción
Medtronic is advising customers to cease use of affected product. Customers are requested to return unused units by following the instructions outlined in the Customer Letter.
Medtronic is advising clinicians who may have used impacted units to monitor their patient's condition to determine if there are any signs of infection. If infection is present, the patient should seek medical attention immediately for treatment.
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 there can be a 2mm +/- overall length difference between various manufacturers pp3 batteries that could be used in niki t34 ambulatory syringe pumps. this could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
Acción
If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed 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.
Notas adicionales en la data
Causa
The current packaging and ifu indicate a five-year shelf life. during long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. a breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.To date, medtronic have not received any complaints as a result of this issue.
Acción
Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product.
In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge has been made aware when multiple carescape monitor b650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. the monitor restart will not be completed until the network issue has been corrected. loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.To date, ge has not received reports of injury as a result of the reboot process.
Acción
GE Healthcare is advising that they will in contact with users to arrange correction of affected products.
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
Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
Acción
Bio-Rad is advising:
- For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step.
- Do not use a suspicious colour agar.
- As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.
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 small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. to date, no injury has been reported to ge as a result of this issue.
Acción
GE is advising they will be in contact with users to arrnage for impacted products to be corrected.
In the interim, users may continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning.
If a brown discolouration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact the local GE Service 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
Stryker has discovered that specific lots of the mako rio system irrigation clip have the potential to fracture. the rio system irrigation clip is a sterile disposable, used to direct saline flow for the burring tool during a mako partial knee surgery. in the event of a break in the mako rio system irrigation clip, potential hazards of a fractured device and/or foreign object (inert particulate left in wound) may occur.
Acción
Stryker is advising customers to inspect inventory and quarantine affected product, Stryker will contact customers to arrange return of affected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Bio-rad have observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
Acción
Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes.
Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the 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
It has been identified by emergo that some raystation/rayplan users have commissioned machines with erroneous beam profile correction parameters. these parameters affect the dose calculated in corners of large or off-axis fields. to the best of our knowledge, the issue has not caused any patient mistreatment.
Acción
Emergo is requesting that users:
Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
- Carefully review all beam model parameters before commissioning.
- Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
- Review any existing photon beam models to ensure that the actions above have been properly performed.
Please educate physics staff about these user responsibilities.
Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.
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
Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
Acción
Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given 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.
Notas adicionales en la data
Causa
Stryker australia has discovered that two (2) lots of tritanium-pl cages, part number 48950066 (lot # a8am) and part number 48954066 (lot # a8t2), were shipped and sold to australia without market release approval. the tritanium-pl cage product family has been registered and approved in australia. however, the specific part numbers 48950066 and 48954066 were not registered in australia.
Acción
Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.
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 australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
Acción
Ortho Clinical Diagnostics is advising:
For VITROS Na+ Slides, GENs 8 & 13:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing.
For VITROS Na+ Slides, GENs 14, 16, 17 & 18:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing.
- It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met:
1. Calibration is successful and Quality Control results are within acceptable limits; and
2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory.
If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
Acción
B. Braun is requesting customers:
1. Identify, quarantine and return affected devices;
2. Do not use affected devices anymore;
3. Patients with affected devices in use should be monitored carefully;
4. Inform the responsible personnel in the relevant facilities; and
5. Confirm receipt of the correspondence as per the instructions given 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.
Notas adicionales en la data
Causa
Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
Acción
Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.
In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ge healthcare has identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Acción
GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible.
GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction.
Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative 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
Smith & nephew have identified that the product visionaire lightweight alignment rod is oversized, preventing mating with the visionaire alignment connector.
Acción
Once the recall acknowledgement has been received and there is product to be retrieved, a Smith & Nephew Representative will go to the hospital to retrieve the affected items are provide replacement products
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Baxter healthcare have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
Acción
Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.