Device product
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Z-1496-2026
Product summary
- Event
- Event 98314
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 204,000 units
- Official record key
device-enforcement:Z-1496-2026
Official wording
Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Code information: Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.
Distribution pattern: US Nationwide distribution in the states of California and Texas.
Derived failure modes
-
Unknown
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.