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

FDA recall notice · announced December 27, 2017 · B. Braun Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Product was distributed nationwide.
Lot/code information: Lot #: J7N965, Exp. 10/31/2020
Quantity: 2,576 containers
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.