Recall Z-2078-2015 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
| Date | Jul 15, 2015 (initiated Jun 15, 2015) |
| Status | Terminated |
| Reason | 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 | 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 wer |
| Quantity | 283 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH, Jun 6, 2006 |