Device product
Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
Z-2741-2024
Product summary
- Event
- Event 94581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2741-2024
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: DYNJRA2040H, Lot Number 23CBH893; DYNJRA2040H, Lot Number 23HBX547; DYNJRA2040H, Lot Number 23JBN538; DYNJRA2040H, Lot Number 24ABQ696; DYNJRA2040H, Lot Number 24CBG746
Distribution pattern: Worldwide
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.