December 2017 FDA Recall Acetic Acid by B. Braun Medical Inc
D-0112-2018 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by B. Braun Medical Inc on December 15, 2017 for the product Acetic Acid. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0112-2018
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
12-15-2017
12-27-2017
2,576 containers
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B. Braun Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide.
10-18-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : J7N965, Exp. 10/31/2020
