FDA-Device2015-07-22Class II
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Sorin Group USA, Inc.
Hazard
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Affected count
2837
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2015Don't want to check this manually?
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