Z-2644-2023Class II

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

Name: Z-2644-2023 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an...
Creator: B. Braun Medical, Inc.
Published: 2023-08-07
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2023-08-07 / Open, Classified / root cause: packaging

FDA source

B. Braun Medical, Inc. began a recall of 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... on 2023-08-07. FDA classified it as Class II and gives the reason as "The sterile blister packaging may be damaged, and sterility may be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2644-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-07
Posted: 2023-09-27
Recalling firm: B Braun Medical Inc
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
Product code: FMF Syringe, Piston
Reason for recall: The sterile blister packaging may be damaged, and sterility may be compromised
Root cause tag: packaging
FDA root cause: 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 [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
Quantity in commerce: 604,800 units
Distribution: US Nationwide distribution in the state of VA.
Product codes and lots: UDI-DI: 04046955597185 Lot Numbers: 22M21C8, 23A09C8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2644-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2643-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-27
Z-2644-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-27

Product code FMF

K063280Class IIInjekt SyringeB.Braun Medical, Inc. / cleared 2006-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)