Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Recall Initiated
- September 5, 2017
- Terminated
- September 23, 2024
- Recall Number
- Z-0490-2019
- Quantity
- 10,440
- Firm Location
- Vernon Hills, IL
Reason for Recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Distribution
AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI
Lot / Code Info
Model # FB-A-400-107 Lot Number: 4J006
Root Cause
Other
Action Taken
Firm sent recall notification letters to customers on 9/5/2017.
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