February 2018 FDA Recall Sodium Chloride by B. Braun Medical Inc
D-0549-2018 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by B. Braun Medical Inc on February 16, 2018 for the product Sodium Chloride. 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-0549-2018

Reason for Recall
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Initiated
02-16-2018
Reported
03-07-2018
Quantity
17,360 plastic irrigation containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79348
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2020
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.

Batch or Lot Expiration Information

Batch# J7N912, Exp 10/31/20

Affected Packages Involved in this Recall

0264-2201-00 Sodium Chloride
0264-2201-10 Sodium Chloride
0264-2201-50 Sodium Chloride
0264-2201-70 Sodium Chloride