The Recall Desk

FDA (Devices) recall action 92910

B. Braun Medical, Inc. recalled 2 products on 2023-10-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-10-04
Critical
0
Units
1,138,800

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2023-10-04

    B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage

    B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2023-10-04

    B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall

    B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.

    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
    Category
    Distribution
    1 state