Class II
Terminated
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.
This recall has been terminated (originally issued March 7, 2018).
- Company
- B. Braun Medical Inc
- Recall Initiated
- February 16, 2018
- Posted
- March 7, 2018
- Recall Number
- D-0549-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,360 plastic irrigation containers
- Firm Location
- Irvine, CA, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Batch # J7N912, Exp 10/31/20
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