Sorin Group USA, Inc. recalls STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Recall date

June 30, 2017

Source

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

Recall number

Z-2772-2017

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, C…

Why it was recalled

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

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

What was recalled

STOCKERT Heater-Cooler System 3T, 240V/60 Hz