Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information: Model # FB-A-400-107 Lot Number: 4J006

Distribution pattern: 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