Recall Z-2077-2015
Sorin Group USA, Inc. · initiated June 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Codes / lots: Product code 16-02-81 Serial number 16S10743-16S11708
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 taken
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.
Details
- Recall number
- Z-2077-2015
- Initiated
- June 15, 2015
- Posted by FDA
- July 15, 2015
- Terminated
- July 25, 2018
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 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…
- Recalling firm
- Sorin Group USA, Inc., Arvada, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2076-2015 Class II | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | 06/15/2015Terminated |
| Z-2078-2015 Class II | Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | 06/15/2015Terminated |
| Z-2079-2015 Class II | Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | 06/15/2015Terminated |
| Z-2080-2015 Class II | Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | 06/15/2015Terminated |
| Z-2081-2015 Class II | Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | 06/15/2015Terminated |