Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated fo
FDA device recall Z-0451-2013 · posted 2012-11-29 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
- Action taken
- 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
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 400 units
- 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
- Date initiated
- 2010-09-16
- Date posted
- 2012-11-29
- Date terminated
- 2012-12-20
- Location
- Roswell, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS (K033021) | Kimberly-Clark Corp. | 2003-11-12 |