Recall Z-2644-2023 ยท FMF Syringe, Piston
B. Braun Medical, Inc.
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
| Date | Sep 27, 2023 (initiated Aug 7, 2023) |
| Status | Open, Classified |
| Reason | The sterile blister packaging may be damaged, and sterility may be compromised |
| Root cause | Under Investigation by firm |
| Action | B. Braun Melsungen AG (BBMAG), manufacturer of Norm-Ject notified B. Braun Medical Inc. (BBMI)of the recall. BBMI notified the US Importer/Distributor Air Tite Products Company Inc. via email on 8/7/23. Letter states reason for recall, health risk and action to take: Review the Product Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is |
| Quantity | 604,800 units |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063280 | INJEKT SYRINGE B.Braun Medical, Inc., Nov 17, 2006 |