CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report

SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket recalled

Smiths Medical ASD is recalling SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket, distributed in 10 states. The recall was initiated on 22 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712

Quantity recalled2120 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1650-2014
FDA event ID: 68094
Recalling firm: Smiths Medical ASD, Rockland, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2014
FDA classified: 22 May 2014
Reported: 28 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

22 Apr 2014	Recall initiated by company
22 May 2014	Classified by FDA	+30 days
28 May 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The hose could separate from the blanket.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU

California Delaware Illinois Kentucky Mississippi North Carolina Tennessee Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

The hose could separate from the blanket.

Which lots are affected?

Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712

Where was it sold?

Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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