—#138338

Product

Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

FDA product code: DWC — Controller, Temperature, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052601
Affected lot / code info: Product code 16-02-95 Serial number 16S12004-16S15385

Why it was recalled

Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Root cause (FDA determination)

Error in labeling

Action the firm took

Sorin Group issued a Field Safety Notice dated June 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and identify any affected devices. For each unit customers were instructed to determine if the device has been maintained according to the Instructions for Use. If yes, customers should strictly adhere to the new Instructions for Use. Customers were also provide with a Response form to confirm they received, read and understood the Field Notice. Customers were instructed to return the completed form to assist in monitoring the effectiveness of the communication. For technical support customers should call 1-800-221-7943, ext 6355. For questions regarding this recall call 303-467-6306.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-06-15
Posted by FDA: 2015-07-15
Terminated: 2018-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138338. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.