FDAFebruary 16, 2018drug
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
What to do
FDA enforcement status: Terminated
Brands named
b braun medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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