Medical Devices Recalls

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.

Product lidstock contains the incorrect expiration date for the product

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Product lidstock contains the incorrect expiration date for the product

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.