Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
FDA Recall Z-0451-2013 · Posted 2012-11-29
Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeDWJ
Date Initiated2010-09-16
Date Terminated2012-12-20
Product Quantity400 units
Reason for Recall
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
Firm Action
Kimberly Clark sent an Urgent Field Corrective Action letter dated September 16, 2010, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were asked to confirm whether their facility as the affected product by faxing the completed Field Corrective Action Response Form to 920-380-6682. Kimberly-Clark will arrange to perform the upgrade at the customer's facility. Customers with questions should call the Field Corrective Action Coordinator at 770-587-7400.
For questions regarding this recall call 770-587-8393.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
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.