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Terminated

Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

FDA Recall Z-2078-2015 · Posted 2015-07-15

Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWC
Date Initiated2015-06-15
Date Terminated2018-07-25
Product Quantity283

Reason for Recall

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

Firm Action

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.

Root Cause

Error in labeling

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052601STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH · 2006-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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