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Vital Signs Devices, a GE Healthcare Company recalls enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC
Recalled July 18, 2012 · FDA recall Z-1972-2012 · Vital Signs Devices, a GE Healthcare
Hazard
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. · FDA Class II
Units
11803 cases
Sold at
Nationwide Distribution.
Description
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.
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.
Manufacturer(s)
Vital Signs Devices, a GE Healthcare Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →