Device product
Stay Safe Cap
Z-0507-2024
Product summary
- Event
- Event 93396
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,236,160 eaches
- Official record key
device-enforcement:Z-0507-2024
Official wording
Reason: Updating the labeling to include additional warnings and contraindications for potential side effects.
Code information: Model No. 050-95012; UDI-DI: 00840861100835; All Lots.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Updating the labeling to include additional warnings and contraindications for potential side effects.