← FDA ENFORCEMENT
D-0353-2025Class II

B. Braun Medical Inc

Recalling firm
B. Braun Medical Inc
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Firm state
CA
Product quantity
32,256 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter

Product description

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

Code / lot info

Lot # J4K936, Exp 7/31/2027

Other recalls SPEQ maps to Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.