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.
FDA Recall Z-2181-2012 · Posted 2012-08-09
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Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeDWJ
Date Initiated2012-04-27
Date Terminated2012-09-05
Product Quantity129 units
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.
Firm Action
Kimberly-Clark sent an "URGENT: FIELD CORRECTIVE ACTION NOTICE" dated April 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Corrective Action Response Form was attached for customers to complete and return. Contact the Field Corrective Action Coordinator at 770-587-7400 for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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