Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Recalled Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Hazard / Issue
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Issued by
FDA
Affected States: 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, SC, TN, TX, UT, VA, VT, WA, WI
Lot/Code Info: Model # FB-A-400-107 Lot Number: 4J006
View official government recall
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