Stay Safe Cap
FDA device recall Z-0507-2024 · posted 2023-12-07 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Updating the labeling to include additional warnings and contraindications for potential side effects.
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- KDJ
- Quantity affected
- 18,236,160 eaches
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-10-10
- Date posted
- 2023-12-07
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS STERILE STAY SAFE CAP (K083542) | Fresenius Medical Care North America | 2008-12-29 |