Recall Z-1650-2014— Smiths Medical ASD, Inc.

Name: FDA recall Z-1650-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-22

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-04-22, terminated 2015-02-27. It names one FDA 510(k) clearance: K040632. 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.. Reason: The hose could separate from the blanket..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-22
Terminated: 2015-02-27
Firm location: Rockland, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K040632 — SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000Smiths Medical Asd, Inc.·cleared 2004-04-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The hose could separate from the blanket.

Data sourced from openFDA. This site is unofficial and independent of the FDA.