Z-0507-2024Class II

Stay Safe Cap

Name: Z-0507-2024 Stay Safe Cap
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2023-10-10
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2023-10-10 / Open, Classified / root cause: labeling and UDI

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Stay Safe Cap on 2023-10-10. FDA classified it as Class II and gives the reason as "Updating the labeling to include additional warnings and contraindications for potential side effects". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0507-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-10
Posted: 2023-12-07
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Stay Safe Cap
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Updating the labeling to include additional warnings and contraindications for potential side effects.
Root cause tag: labeling and UDI
FDA 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 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].
Quantity in commerce: 18,236,160 eaches
Distribution: US Nationwide distribution.
Product codes and lots: Model No. 050-95012; UDI-DI: 00840861100835; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0507-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0507-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-07

Product code KDJ

K083542Class IIFresenius Sterile Stay Safe CapFresenius Medical Care North America / cleared 2008-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)