Other Medical Devices

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.

The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

There is an error in the caddy artwork that misidentifies a specific plate and screw.

There is an error in the caddy artwork that misidentifies a specific plate and screw.