D-0112-2018 Class II Terminated

Recalled by B. Braun Medical Inc — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
December 15, 2017
Termination Date
October 18, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,576 containers

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

Distribution Pattern

Product was distributed nationwide.

Code Information

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