Medtronic Perfusion Systems 2022-01-19 Health serious FDA
Health · FDA · Recall #FDA-Z-0491-2022
Medtronic Custom Perfusion kits, with the following product descriptions and… Recall
Issued January 19, 2022 · Medtronic Perfusion Systems
In January 2022, Medtronic Perfusion Systems recalled the Medtronic Custom Perfusion kits, with the following product descriptions and…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
What you should do
- 1 Stop using Medtronic Custom Perfusion kits, with the following product descriptions and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Perfusion Systems 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
- Medtronic Perfusion Systems
- Category
- Health
- Recall date
- January 19, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The
- Recall number
- FDA-Z-0491-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Perfusion Systems has 11 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.