B. Braun NORM-JECT Luer Solo recall: Sterility Concern
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
Why was B. Braun NORM-JECT Luer Solo recalled?
The sterile blister packaging may be damaged, and sterility may be compromised
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8
- 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
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 534,000 units
- Distribution
- US Nationwide distribution in the state of VA.
- Recall date
- October 4, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)