Recall Z-0887-2022— Maquet Cardiovascular, LLC

Name: FDA recall Z-0887-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-09

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2022-02-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.. Reason: Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-02-09
Firm location: Wayne, NJ, United States

Product description

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

Reason for recall

Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.

Data sourced from openFDA. This site is unofficial and independent of the FDA.