Recall Z-0451-2013— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2010-09-16, terminated 2012-12-20. It names one FDA 510(k) clearance: K033021. 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: Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-09-16
- Terminated
- 2012-12-20
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.