B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered

FDA device recall Z-2644-2023 · posted 2023-09-27 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FMF

Quantity affected

604,800 units

Distribution

US Nationwide distribution in the state of VA.

Date initiated

2023-08-07

Date posted

2023-09-27

Location

Allentown, PA

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