Recall Z-0507-2024 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
| Date | Dec 7, 2023 (initiated Oct 10, 2023) |
| Status | Open, Classified |
| 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 med |
| Quantity | 18,236,160 eaches |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083542 | FRESENIUS STERILE STAY SAFE CAP Fresenius Medical Care North America, Dec 29, 2008 |