0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc...
FDA Recall #D-0112-2018 — Class II — December 15, 2017
Product Description
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
Reason for Recall
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Recalling Firm
B. Braun Medical Inc — Irvine, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,576 containers
Distribution
Product was distributed nationwide.
Code Information
Lot #: J7N965, Exp. 10/31/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated