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NORM-JECT recallZ-2643-2023 · B. Braun Medical, Inc. · initiated Aug 7, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The sterile blister packaging may be damaged, and sterility may be compromised

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-2643-2023
Status
Open, Classified
Initiated by the company
Aug 7, 2023
Posted by the FDA
Sep 27, 2023
Recalling firm
B. Braun Medical, Inc.
Quantity
534,000 units
Product code
FMF
FDA submissions
K063280
Distribution
US Nationwide distribution in the state of VA.

Product description

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 (models, lots, serial numbers)

UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K063280 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92910).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page