Class 2 Device Recall STOCKERT HEATERCOOLER SYSTEM 3T

• Date Initiated by Firm: June 15, 2015
• Date Posted: July 15, 2015
• Recall Status: Terminated on July 25, 2018
• Recall Number: Z-2077-2015
• Recall Event ID: 71593
• 510(K)Number: K052601
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
• Code Information: Product code 16-02-81 Serial number 16S10743-16S11708
• Recalling Firm/ Manufacturer: Sorin Group USA, Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: Cheri Voorhees; 303-467-6306
• Manufacturer 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.
• FDA Determined Cause: Error in labeling
• 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.
• Quantity in Commerce: 21
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWC