B. Braun Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2643-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 7, 2023

Date Posted: October 4, 2023

Recall Number: Z-2643-2023

Event ID: 92910

Reason for Recall:

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

Status: Ongoing

Product Quantity: 534,000 units

Code Information:

UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8

Distribution Pattern:

US Nationwide distribution in the state of VA.

Voluntary or Mandated:

Voluntary: Firm initiated