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Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Recalled November 28, 2018 · FDA recall Z-0490-2019 · Medex Cardio-Pulmonary Inc.,
Hazard
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. · FDA Class II
Units
10,440
Sold at
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
Description
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Manufacturer(s)
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →