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.
FDA Recall Z-1650-2014 · Posted 2014-05-22
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Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeDWJ
Date Initiated2014-04-22
Date Terminated2015-02-27
Product Quantity2120 devices
Reason for Recall
The hose could separate from the blanket.
Firm 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.
Root Cause
Process change control
Distribution Pattern
Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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