FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Stay Safe Cap
- Recall number
- Z-0507-2024
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Stay Safe Cap
- Status
- Open, Classified
- Initiated
- 2023-10-10
- Posted
- 2023-12-07
- Terminated
- not on file
- Reason
- Updating the labeling to include additional warnings and contraindications for potential side effects.
- Root cause
- Labeling design
- Action
- Consignees were mailed an IMPORTAND MEDICAL DEVICE INFORMATION notification dated 10/10/23 vis USPS. This notification is to bring awareness to consignees that Fresenius is updating the labeling to their Stay Safe Cap to include additional warnings and contraindications for potential side effects for P/N 05-95012. Increased exposure to povidone-iodine, which is present in the Stay Safe Cap, could lead to iodine-induced hypothyroidism and hypersensitivity. Clinicians are asked to not use these devices in known cases of povidone-iodine allergy. Fresenius is updating labeling to include these medical warnings and contraindications. Any clinical or medical questions can be directed to the firm at 1-855-616-2309. Consignees are asked to return the provided Reply Form by fax to 781-966-9796 or 781-472-7413, ATTN: Quality Department, or by email to NOTIFYRA@fmc-na.com.
- Quantity
- 18,236,160 eaches
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
- 510(k) numbers
- ["K083542"]
- PMA numbers
- not on file
- Product code
- KDJ
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28