Stay Safe Cap
- Recall Initiated
- October 10, 2023
- Posted
- December 7, 2023
- Recall Number
- Z-0507-2024
- Quantity
- 18,236,160 eaches
- Firm Location
- Waltham, MA
Reason for Recall
Updating the labeling to include additional warnings and contraindications for potential side effects.
Distribution
US Nationwide distribution.
Lot / Code Info
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Root Cause
Labeling design
Action Taken
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.