FDA-Drug2018-03-07Class II
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.
B. Braun Medical Inc
Hazard
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.
Sold states
Nationwide in the USA
Affected count
17,360 plastic irrigation containers
Manufactured in
2525 McGaw Ave, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0549-2018Don't want to check this manually?
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