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

Recall Insight

This FDA Devices action (record #Z-2644-2023) was formally reported on October 4, 2023, with the manufacturer initiating the action on August 7, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records indicate 604,800 units units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The sterile blister packaging may be damaged, and sterility may be compromised Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of VA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.