Z-1972-2012Class II

enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200...

Name: Z-1972-2012 enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200...
Creator: Vital Signs Devices, a GE Healthcare Company
Published: 2012-02-20
License: https://open.fda.gov/license/

Vital Signs, Inc. / initiated 2012-02-20 / Terminated / root cause: design

FDA source

Vital Signs Devices, a GE Healthcare Company began a recall of enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The... on 2012-02-20. FDA classified it as Class II and gives the reason as "The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours". 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-1972-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-20
Posted: 2012-07-09
Terminated: 2013-08-19
Recalling firm: Vital Signs, Inc.
Product: enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is 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: The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours.
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included customer instructions and a Customer Response Form to be completed and returned to the firm. Contact Customer Service at 1-800-932-0760 for questions regarding this recall.
Quantity in commerce: 11803 cases
Distribution: Nationwide Distribution.
Product codes and lots: a) 510(k): K060537 b) Medical device listing number: D071942 All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products: Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1972-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

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)