FDA-Device2018-11-28Class II
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Hazard
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Sold 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, PR, SC, TN, TX, UT, VA, VT, WA, and WI
Affected count
10,440
Manufactured in
330 Corporate Woods Pkwy, N/A, Vernon Hills, IL, United States
Products
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2019Don't want to check this manually?
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