Recall Z-2643-2023— B. Braun Medical, Inc.

Name: FDA recall Z-2643-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-07

Class II · Ongoing

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2023-08-07. It names one FDA 510(k) clearance: K063280. 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. Reason: The sterile blister packaging may be damaged, and sterility may be compromised.

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-07
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K063280 — INJEKT SYRINGEB.Braun Medical, Inc.·cleared 2006-11-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.