Recall Z-2181-2012 ยท DWJ System, Thermal Regulating
Kimberly-Clark Corporation
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
| Date | Aug 9, 2012 (initiated Apr 27, 2012) |
| Status | Terminated |
| Reason | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. |
| Root cause | Device Design |
| Action | Kimberly-Clark sent an "URGENT: FIELD CORRECTIVE ACTION NOTICE" dated April 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Corrective Action Response Form was attached for customers to complete and return. Contact the Field Corrective Action Coordinator at 770-587-7400 for questions regarding this notice. |
| Quantity | 129 units |
| Distribution | Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033021 | KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS Kimberly-Clark Corp., Nov 12, 2003 |