Z-1650-2014Class II

SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are...

Name: Z-1650-2014 SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are...
Creator: Smiths Medical ASD, Inc.
Published: 2014-04-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-04-22 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's... on 2014-04-22. FDA classified it as Class II and gives the reason as "The hose could separate from the blanket". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1650-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-22
Posted: 2014-05-22
Terminated: 2015-02-27
Recalling firm: Abbott Medical
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: The hose could separate from the blanket.
FDA root cause: Process change control
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.
Quantity in commerce: 2120 devices
Distribution: Worldwide Distribution Including the States of CA, IL, KY, MS, NC, TN, TX, WA, WI and the Countries of BH, DE, NO, RU
Product codes and lots: Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-22

Product code DWJ

K040632Class IISnuggle Warm 4000 Convective Warming System, Model Sw4000Smiths Medical Asd, Inc. / cleared 2004-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)