Agency classClass IIOur severity:High FDA (Drugs)·D-0586-2025·Announced 2025-08-20

Sodium chloride injection containers recalled over potential fluid leakage at weld site

B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable solution is a potential harm and no injuries are reported.

Plain-English summary

0.9% Sodium Chloride Injection USP, L 8000, in 1000 mL Excel containers, NDC 0264-7800-00, is being recalled. The prescription-only product is a sterile, non-pyrogenic, single dose container made by B. Braun Medical Inc. of Bethlehem, Pennsylvania. The affected product is lot J5C919 with an expiry of 08/31/2027, and the recall covers 23,100 containers distributed nationwide.

The recall was issued for lack of assurance of sterility, because of the potential for fluid leakage at one of the weld sites on the container. The FDA classified the action as Class II.

Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow B. Braun's instructions for return or replacement.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: B BRAUN MEDICAL INC
Category: Drug — Intravenous Solution
Hazard: sterility-assurance
container-leak
injectable
class-ii
Affected units: 23,100

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)

Lot #: J5C919
Exp. 08/31/2027

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 →

Same brand · SODIUM CHLORIDE

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Same hazard · sterility assurance