Class II — Kimberly-Clark Corporation
| Recalling firm | KIMBERLY-CLARK CORPORATION |
|---|---|
| Registered facility | KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | 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. |
| 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. |
| Initiated | 2012-04-27 |
| Classified | 2012-08-09 |
| Terminated | 2012-09-05 |
| Recall number | Z-2181-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kimberly-Clark Corporation (Z-2181-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62596/
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