Device product
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Z-0007-2024
Product summary
- Event
- Event 92906
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 124,773 boxes total
- Official record key
device-enforcement:Z-0007-2024
Official wording
Reason: There is a potential for blood backfill leakage and foreign material.
Code information: UDI-DI: 16945060500101; All Lots
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
foreign material