Recall Z-2181-2012— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2012-04-27, terminated 2012-09-05. It names one FDA 510(k) clearance: K033021. 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: 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..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-27
- Terminated
- 2012-09-05
- 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. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.