Fresenius Medical Care Holdings, Inc. 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0507-2024
Stay Safe Cap Recall
Issued December 13, 2023 · Fresenius Medical Care Holdings, Inc.
In December 2023, Fresenius Medical Care Holdings, Inc. recalled the Stay Safe Cap, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Updating the labeling to include additional warnings and contraindications for potential side effects.
What you should do
- 1 Stop using Stay Safe Cap 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
- December 13, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0507-2024
- 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 903rd Health recall we've logged in 2023.