Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0490-2019

FDA classification

Class II

Brand / firm

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1