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U.S. Department of Health and Human Services

Class 2 Device Recall SW2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket

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  Class 2 Device Recall SW2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket see related information
Date Initiated by Firm April 22, 2014
Date Posted May 22, 2014
Recall Status1 Terminated 3 on February 27, 2015
Recall Number Z-1650-2014
Recall Event ID 68094
510(K)Number K040632  
Product Classification SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket - Product Code DWJ
Product 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.
Code Information Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712
Recalling Firm/
Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information Contact Shirley Duggan
Manufacturer Reason
for Recall
The hose could separate from the blanket.
FDA Determined
Cause 2
Process change control
Action 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.
Quantity in Commerce 2120 devices
Distribution Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = SMITHS MEDICAL ASD, INC.