FDA recall D-0112-2018

B. Braun Medical Inc · Class II · drug

Product

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

Reason for recall

Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap

Distribution

Product was distributed nationwide.

Key facts

Status
Terminated
Initiation date
2017-12-15
Report date
2017-12-27
Termination date
2018-10-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0112-2018