Fresenius Medical Care Holdings, Inc. Stay Safe Cap Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stay Safe Cap
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
Model No. 050-95012, UDI-DI: 00840861100835, All Lots.
Products Sold
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Fresenius Medical Care Holdings, Inc. is recalling Stay Safe Cap due to Updating the labeling to include additional warnings and contraindications for potential side effects.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Updating the labeling to include additional warnings and contraindications for potential side effects.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026