D-0549-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 7, 2018
- Initiation Date
- February 16, 2018
- Termination Date
- January 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,360 plastic irrigation containers
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch # J7N912, Exp 10/31/20