Z-0507-2024 Class II Ongoing
FDA device recall Z-0507-2024 was initiated by Fresenius Medical Care Holdings, Inc. on October 10, 2023 and is designated Class II. Reason for recall: Updating the labeling to include additional warnings and contraindications for potential side effects. The recall status is ongoing. Affected quantity: 18,236,160 eaches.
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.