B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall
B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product—a sterile injection device where packaging damage may compromise sterility—where no injuries have been reported. Per the severity rubric, this fits the High category: risk-of-harm products where injury has not yet been reported.
Plain-English summary
B.Braun Medical, Inc. is recalling B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes due to potential damage to the sterile blister packaging. These syringes are intended to deliver or withdraw accurate metered doses of fluid to or from the body via injection.
The recall was initiated because damaged packaging may compromise the sterility of the device. Lot numbers 22M21C8 and 23A09C8 are affected. Approximately 604,800 units were distributed nationwide, primarily in Virginia through distributor Air-Tite Products Co., Inc.
Consumers and healthcare facilities should stop using the recalled syringes immediately. Contact B.Braun Medical, Inc. or the distributor for instructions on returning or disposing of the product properly. If any of these syringes have been used, consult a healthcare provider.
The recalled product
- 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
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 604,800
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: 04046955597185 Lot Numbers: 22M21C8
- 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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