B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage
B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device where sterility compromise poses an infection risk. However, no illnesses or injuries have been reported, and the hazard is theoretical (packaging may be damaged). Per the rubric, theoretical hazards with no reported illness score at most 3.
Plain-English summary
B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are sterile medical devices intended for delivering or withdrawing fluids from the body. The product is manufactured by B. Braun Medical, Inc. and distributed by Air-Tite Products Co., Inc., distributed in Virginia.
The recall was initiated because the sterile blister packaging may be damaged, which could compromise the sterility of the syringes. Sterility is critical for these medical devices intended for injection use.
Approximately 534,000 units are affected. The recall includes lot numbers 22M28C8 and 23A09C8. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare facilities should immediately stop using affected syringes and contact their supplier for replacement or disposal instructions.
The recalled product
- 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
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Injector
- Affected units
- 534,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04046955597031 Lot Numbers: 22M28C8
- 23A09C8
Distribution
Part of a larger recall action
This product is one of 2 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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