FDA-Device2017-08-02Class II
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Sorin Group USA, Inc.
Hazard
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.
Sold states
"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, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
Affected count
7,546 units
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2774-2017Don't want to check this manually?
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