Recalls / —

—#204253

Product

Stay Safe Cap

FDA product code

KDJ — Set, Administration, For Peritoneal Dialysis, Disposable

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K083542

Affected lot / code info

Model No. 050-95012; UDI-DI: 00840861100835; All Lots.

Why it was recalled

Updating the labeling to include additional warnings and contraindications for potential side effects.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm

Fresenius Medical Care Holdings, Inc.

Address

920 Winter St, Bld 920, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2023-10-10

Posted by FDA

2023-12-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.