Device product
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Z-2515-2024
Product summary
- Event
- Event 94584
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2515-2024
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: Lot Number 2019072590
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.