FDA Enforcement
Class II
Ongoing
Stay Safe Cap
Recall: Z-0507-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0507-2024
- Event ID
- 93396
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 13, 2023
- Initiation Date
- October 10, 2023
- Classification Date
- December 7, 2023
- Address
- 920 Winter St Bld 920, Waltham, MA, 02451-1521, United States
Description
Stay Safe Cap
Reason
Updating the labeling to include additional warnings and contraindications for potential side effects.
Code Info
Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Distribution
US Nationwide distribution.
Quantity
18,236,160 eaches