Kimberly-Clark Patient Warming System — Class II medical device recall Z-0451-2013
Terminated recall by Kimberly-Clark Corporation, reported 2012-12-05, distributed nationwide. Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
| Recall number | Z-0451-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kimberly-Clark Corporation, Roswell, GA, United States |
| Recall initiated | 2010-09-16 |
| Classified | 2012-11-29 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2012-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 400 units |
| Serial numbers | SA07180001, SA07180002, SA07180003, SA07180004, SA07180005, SA07180006, SA07228001, SA07228002, SA07228003, SA07228004, SA07228005, SA07228006, SA07228007, SA07228008, SA07250001, SA07250002, SA07250003, SA07250004, SA07250005, SA07257001, SA07257002, SA07257003, SA07257004, SA07257005, SA07257006 and 236 more |
| Model numbers | 1000 |
Product
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Reason for recall
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
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-0451-2013. 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.