B. Braun Medical, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8
Products Sold
UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8
B. Braun Medical, Inc. is recalling B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an due to The sterile blister packaging may be damaged, and sterility may be compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The sterile blister packaging may be damaged, and sterility may be compromised
Recommended Action
Per FDA guidance
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 to be extended to the consumer level. 2. Determine your current inventory of the affected items within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached Product Recall Acknowledgement Form , record the total number of individual impacted units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Recall Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Product Recall Acknowledgement Form , a B. Braun OEM Sales Service representative will contact you with instructions on product disposition. Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026