FDAFDA · Food and drugs·Recall number Z-2080-2015
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Published July 22, 2015 · Recall initiated: June 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sorin Group USA, Inc.
- Distributor
- 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.
- Lot
- Product code 16-02-85 Serial number 16S10958-16S15634
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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