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.
This recall has been terminated (originally issued May 22, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- April 22, 2014
- Posted
- May 22, 2014
- Terminated
- February 27, 2015
- Recall Number
- Z-1650-2014
- Quantity
- 2120 devices
- Firm Location
- Rockland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The hose could separate from the blanket.
Distribution
Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
Lot / Code Info
Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712
Root Cause
Process change control
Action Taken
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.
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