Other Medical Devices

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.

Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.

the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

The external power supply input is overheating at the connection to the freezer.

Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.

Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.