Recall Z-2207-2016 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves
| Date | Jul 14, 2016 (initiated Jun 8, 2016) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo Cardiovascular Systems (Terumo CVS) initiated a voluntary recall on 06/08/2016, by mailing certifed letters to customers. Terumo CVS is notifying all users of its heater-cooler devices that the distributor, Intercon Chemical Company, no longer sells the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. However, the identical sanitizer is available from other sources. This notice applies to the following Terumo CVS heater-cooler devices: Sarns" TCM and TCM II Cooling and Heating Systems Sarns" Dual Cooler-Heaters HX2" Temperature Managemen |
| Quantity | 6412 units |
| Distribution | Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM Terumo Cardiovascular Systems Corp., Nov 21, 2007 |