Recall Z-0451-2013 ยท DWJ System, Thermal Regulating
Kimberly-Clark Corporation
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
| Date | Nov 29, 2012 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. |
| Root cause | Component design/selection |
| Action | Kimberly Clark sent an Urgent Field Corrective Action letter dated September 16, 2010, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were asked to confirm whether their facility as the affected product by faxing the completed Field Corrective Action Response Form to 920-380-6682. Kimberly-Clark will arrange to perform the upgrade at the customer's facility. Customers with questions should call the Field Corrective Action Coordinator at 770-587-7400. For questions regarding this recall call 770-587-8393. |
| Quantity | 400 units |
| Distribution | Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI |
| 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 |