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Recall Observatory FDA recall evidence

Drug product

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

D-0112-2018

December 15, 2017

Class II

Product summary

Firm
B. Braun Medical Inc
Event
Event 78767
Status
Terminated
Classification
Class II
Quantity
2,576 containers
Official record key
drug-enforcement:D-0112-2018

Official wording

Reason: Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

Code information: Lot #: J7N965, Exp. 10/31/2020

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter