—#126932

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.

FDA product code: DWJ — System, Thermal Regulating
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K040632
Affected lot / code info: Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712

Why it was recalled

The hose could separate from the blanket.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 160 Weymouth St, Rockland, Massachusetts 02370-1136

Distribution

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

Timeline

Recall initiated: 2014-04-22
Posted by FDA: 2014-05-22
Terminated: 2015-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.