Maquet Cardiovascular, LLC 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0887-2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. Recall
Issued April 13, 2022 · Maquet Cardiovascular, LLC
In April 2022, Maquet Cardiovascular, LLC recalled the Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Maquet Cardiovascular, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Maquet Cardiovascular, LLC
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thaila
- Recall number
- FDA-Z-0887-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Maquet Cardiovascular, LLC has 7 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.