Z-3040-2011

enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable...

Name: Z-3040-2011 enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable...
Creator: Vital Signs Devices, a GE Healthcare Company
Published: 2011-06-30
License: https://open.fda.gov/license/

Vital Signs, Inc. / initiated 2011-06-30 / Terminated / root cause: design

FDA source

Vital Signs Devices, a GE Healthcare Company began a recall of enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply... on 2011-06-30. The reason FDA records is "enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3040-2011
Status: Terminated
Initiated: 2011-06-30
Posted: 2011-08-19
Terminated: 2013-06-14
Recalling firm: Vital Signs, Inc.
Product: enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy.
Quantity in commerce: 1307 units
Distribution: Worldwide Distribution - USA (nationwide) and the country of Vietnam
Product codes and lots: K060537 D071942 Serial numbers: 00110412 00110497 00111507 00111633 00111718 00111719 00111816 00111835 00110790 00110946 00111686 00111691 00111916 00111764 00111787 00111897 00111939 00112078 00112200 00111880 00111906 00111733 00111664 00111668 00111672 00111673 00111699 00111745 00111749 00111771 00111773 00111786 00111807 00111817 00111832 00111865 00111886 00111891 00111898 00111954 00111975 00111996 00111997 00112042 00112071 00112106 00111703

Product code LGZ

K060537Class IIEflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow Ac Power Supply, Model 120Enginivity, LLC / cleared 2006-06-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)