Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Cont
FDA device recall Z-2181-2012 · posted 2012-08-09 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 129 units
- Distribution
- 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.
- Date initiated
- 2012-04-27
- Date posted
- 2012-08-09
- Date terminated
- 2012-09-05
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |