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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 Blanketsee related information
Date Initiated by FirmApril 22, 2014
Date PostedMay 22, 2014
Recall Status1 Terminated 3 on February 27, 2015
Recall NumberZ-1650-2014
Recall Event ID 68094
510(K)NumberK040632 
Product Classification SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket - Product Code DWJ
ProductSW-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/
Manufacturer		 Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information ContactShirley Duggan
781-878-8011
Manufacturer Reason
for Recall		The hose could separate from the blanket.
FDA Determined
Cause 2		Process change control
ActionOn 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 Commerce2120 devices
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DWJ
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