The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0347-2023·Announced 2023-03-01

Sodium Chloride Injection Recalled for Incomplete Seal and Potential Leakage

B. Braun Medical is recalling 0.9% Sodium Chloride Injection due to possible incomplete container seals that may leak. The recall involves 483,229 bags distributed nationwide.

The agency’s classification

FDA (Drugs): 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: No illnesses or hospitalizations are reported in the source. This is an FDA Class II recall with a theoretical hazard (incomplete seals 'may' cause leakage) and no confirmed harm, consistent with 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

B. Braun Medical Inc. is recalling certain batches of 0.9% Sodium Chloride Injection, USP, in 500 mL Excel Plus containers. These products are used for intravenous infusion. The recall affects 483,229 bags distributed nationwide.

The recall is due to lack of sterility assurance. Some batches may have incomplete seals near the port assembly, potentially causing microscopic channel leaks. If the seal is compromised, the product's sterility cannot be assured.

Affected lot numbers are: 0061794230 (exp. 01/31/2024), 0061794232 (exp. 01/31/2024), 0061797779 (exp. 02/29/2024), 0061797780 (exp. 02/29/2024), 0061797781 (exp. 02/29/2024), 0061797783 (exp. 02/29/2024), 0061797784 (exp. 03/31/2024), 0061797785 (exp. 03/31/2024), 0061797786 (exp. 03/31/2024), 0061797787 (exp. 03/31/2024), 0061797788 (exp. 03/31/2024), and 0061809680 (exp. 04/30/2024).

Healthcare facilities, pharmacies, and patients should immediately check for these lot numbers. Inventory from affected lots should not be used. Patients who may have received infusions from these batches should contact their healthcare provider.

The recalled product

Product
SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand
SODIUM CHLORIDE
Manufacturer
B. Braun Medical Inc.
Category
Drug — Intravenous Injectable
Hazard
Affected units
483,229

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 (12)

  • Lots: 0061794230 Exp. 01/31/2024
  • 0061794232 Exp. 01/31/2024
  • 0061797779 Exp. 02/29/2024
  • 0061797780 Exp. 02/29/2024
  • 0061797781 Exp. 02/29/2024
  • 0061797783 Exp. 02/29/2024
  • 0061797784 Exp. 03/31/2024
  • 0061797785 Exp. 03/31/2024
  • 0061797786 Exp. 03/31/2024
  • 0061797787 Exp. 03/31/2024
  • 0061797788 Exp. 03/31/2024
  • 0061809680 Exp. 04/30/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B. Braun Medical Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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