Fresenius Medical Care Holdings, Inc. 2024-05-29 Health serious FDA
Health · FDA · Recall #FDA-Z-1866-2024
Blood Pump Rotor, Model Number: F40015481 Rev A Recall
Issued May 29, 2024 · Fresenius Medical Care Holdings, Inc.
In May 2024, Fresenius Medical Care Holdings, Inc. recalled the Blood Pump Rotor, Model Number: F40015481 Rev A, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
What you should do
- 1 Stop using Blood Pump Rotor, Model Number: F40015481 Rev A right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Medical Care Holdings, Inc. 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
- Fresenius Medical Care Holdings, Inc.
- Category
- Health
- Recall date
- May 29, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1866-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Medical Care Holdings, Inc. has 8 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.