Kimberly Clark Patient Warming System — Class II medical device recall Z-2181-2012
Terminated recall by Kimberly-Clark Corporation, reported 2012-08-15, distributed nationwide. A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability
| Recall number | Z-2181-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kimberly-Clark Corporation, Roswell, GA, United States |
| Recall initiated | 2012-04-27 |
| Classified | 2012-08-09 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2012-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 129 units |
| Lot numbers | 4297, 4324, 4332, 4519, 4559, 4572 |
| Serial numbers | 4297, 4324, 4332, 4519, 4559, 4572, SA08017027, SA08017028, SA08017029, SA08017030, SA08017031, SA08017032, SA08017033, SA08017034, SA08017035, SA08017036, SA08017037, SA08017038, SA08017039, SA08017040, SA08017041, SA08017042, SA08017043, SA08017044, SA08017045 and 104 more |
| Model numbers | 01000-01, 01000-01R, 1000 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2181-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.