Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage
B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags 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 irrigation solution is a potential harm and no injuries are reported.
Plain-English summary
0.9% Sodium Chloride Irrigation USP, an isotonic solution for irrigation in 3000 mL bags and available on prescription only, from B. Braun Medical Inc. of Bethlehem, Pennsylvania, NDC 0264-7388-60, is being recalled. Affected lots are J4C521, J4C516 and J4C524, all expiring 28FEB2027. The recall covers 16,228 bags distributed nationwide.
The recall was issued for lack of assurance of sterility, because of the potential for fluid leakage from the port due to port misalignment. The FDA classified the action as Class II.
Hospitals and pharmacies holding these lots should quarantine them, stop using them, and follow B. Braun's instructions for return or replacement.
The recalled product
- Product
- SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
- Brand
- SODIUM CHLORIDE FOR IRRIGATION
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Irrigation Solution
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 (4)
- Lot#: : J4C521
- J4C516
- J4C524
- Exp. : 28FEB2027.
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 →Related recalls
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