FDA Recall Terminated

Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Recall: Z-0451-2013 · Initiated September 16, 2010

Recall

Recall Number
Z-0451-2013
Event Number
63649
Firm
Kimberly-Clark Corporation
FEI Number
1000015879
Product Code
DWJ
Status
Terminated
Root Cause
Component design/selection
Initiated
September 16, 2010
Posted
November 29, 2012
Terminated
December 20, 2012
Address
1400 Holcomb Bridge Rd, Roswell, GA, 30076

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

Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

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.

Distribution

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

Quantity

400 units