SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
Recall
- Recall Number
- Z-1650-2014
- Event Number
- 68094
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 1221261
- Product Code
- DWJ
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- April 22, 2014
- Posted
- May 22, 2014
- Terminated
- February 27, 2015
- Address
- 160 Weymouth St, Rockland, MA, 02370-1136
Description
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
The hose could separate from the blanket.
On April 24, 2014, consignees were notified of the recall via letter. They were instructed to do the following: Inspect inventory and segregate any unused Blankets listed in the notification, complete and return the attached Confirmation Form by fax or e-mail within 7 days of receipt of this notice, and destroy the product.
Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
2120 devices