Z-0507-2024 Class II Ongoing

Recalled by Fresenius Medical Care Holdings, Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
December 13, 2023
Initiation Date
October 10, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,236,160 eaches

Product Description

Stay Safe Cap

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

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