Device product
Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
Z-2778-2024
Product summary
- Event
- Event 94586
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2778-2024
Official wording
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Code information: MNS8250, Lot Number 2022111790
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.