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U.S. Department of Health and Human Services

Class 2 Device Recall NormJect

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  Class 2 Device Recall NormJect see related information
Date Initiated by Firm August 07, 2023
Date Posted September 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-2644-2023
Recall Event ID 92910
510(K)Number K063280  
Product Classification Syringe, piston - Product Code FMF
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
Code Information UDI-DI: 04046955597185 Lot Numbers: 22M21C8, 23A09C8
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact SAME
610-596-0500
Manufacturer Reason
for Recall		 The sterile blister packaging may be damaged, and sterility may be compromised
FDA Determined
Cause 2		 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 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
Quantity in Commerce 604,800 units
Distribution US Nationwide distribution in the state of VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = B. BRAUN MEDICAL, INC.
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