stay.safe recallZ-0507-2024 · Fresenius Medical Care Holdings, Inc. · initiated Oct 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Updating the labeling to include additional warnings and contraindications for potential side effects.
FDA root cause category: Labeling design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0507-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 10, 2023
- Posted by the FDA
- Dec 7, 2023
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 18,236,160 eaches
- Product code
- KDJ
- FDA submissions
- K083542
- Distribution
- US Nationwide distribution.
Product description
Stay Safe Cap
Code information (models, lots, serial numbers)
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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