Drug 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.
D-0549-2018
Product summary
- Event
- Event 79348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,360 plastic irrigation containers
- Official record key
drug-enforcement:D-0549-2018
Official wording
Reason: 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.
Code information: Batch # J7N912, Exp 10/31/20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter