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Terminated

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.

FDA Recall Z-3040-2011 · Posted 2011-08-19

Recalling FirmVital Signs Devices, a GE Healthcare Company
Recall StatusTerminated
Product CodeLGZ
Date Initiated2011-06-30
Date Terminated2013-06-14
Product Quantity1307 units

Reason for Recall

enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the country of Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060537EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120Enginivity, LLC · 2006-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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