| Class 2 Device Recall NormJect |  |
Date Initiated by Firm | August 07, 2023 |
Date Posted | September 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2643-2023 |
Recall Event ID |
92910 |
510(K)Number | K063280 |
Product Classification |
Syringe, piston - Product Code FMF
|
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 |
Code Information |
UDI-DI: 04046955597031
Lot Numbers: 22M28C8, 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 | 534,000 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
|
|
|
|