Device product
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
Z-2643-2023
Product summary
- Event
- Event 92910
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 534,000 units
- Official record key
device-enforcement:Z-2643-2023
Official wording
Reason: The sterile blister packaging may be damaged, and sterility may be compromised
Code information: UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8
Distribution pattern: US Nationwide distribution in the state of VA.
Derived failure modes
-
Sterility assurance
sterility may be compromised