Device product
Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
Z-2988-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2988-2024
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: DYNJRA0377B, Lot Number 19DDB791 ; DYNJRA0377B, Lot Number 21KDA359 ; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243
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.