Recall Z-2208-2016 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradie
| 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
| K841402 | TEMPERATURE CONTROL & MONITOR Sams, Inc., Jun 11, 1984 |