Drug Enforcement D-0353-2025

Presence of Particulate Matter

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

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Product Information

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
Product quantity
32,256 Bottles
Reason for recall
Presence of Particulate Matter
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to 12 distributors who may have further distributed the product nationwide.

Location & Firm

Recalling firm
B. Braun Medical Inc
Address
2525 Mcgaw Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0353-2025
Event ID
96605
Recall initiation date
March 31, 2025
Center classification date
April 8, 2025
Code info
Lot # J4K936, Exp 7/31/2027
More code info
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