FDA-Device2012-07-18Class II
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.
Vital Signs Devices, a GE Healthcare Company
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.
Sold states
Nationwide Distribution.
Affected count
11803 cases
Manufactured in
20 Campus Rd, Totowa, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1972-2012Don't want to check this manually?
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