FDA recall Z-2644-2023

B. Braun Medical, Inc. · Class II · device

Product

B.Braun NORM-JECT Luer Lock 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-4606728-02

Reason for recall

The sterile blister packaging may be damaged, and sterility may be compromised

Distribution

US Nationwide distribution in the state of VA.

Key facts

Status
Ongoing
Initiation date
2023-08-07
Report date
2023-10-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2023