PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 4, 2023 Initiated: August 7, 2023 #Z-2643-2023

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

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
534,000 units
Distribution
US Nationwide distribution in the state of VA.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical, Inc.. Units affected: 534,000 units.
Why was this product recalled?
The sterile blister packaging may be damaged, and sterility may be compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2643-2023.