EFLOW IV FLUID WARMER - Model 200

2 recalls, same reason

• Terminated Z-1385-2019 FDA Class I ·initiated 13 Mar 2019
• Terminated Z-1386-2019 FDA Class I ·initiated 13 Mar 2019

Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

• Terminated Z-1972-2012 FDA Class II ·initiated 20 Feb 2012

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.

• Terminated Z-3040-2011 FDA Unclassified (pre-2012) ·initiated 30 Jun 2011

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

• Terminated Z-2380-2010 FDA Unclassified (pre-2012) ·initiated 15 Jul 2010

The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.

• Terminated Z-2008-2009 FDA Unclassified (pre-2012) ·initiated 23 Mar 2009

1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse failure or localized circuit board overheating with possible smoldering and discoloration. 2. Electromagnetic (EMI) Interference associated with the Warmer may produce artifact in ECG, EEG, or EMG records (cardiac or neuro monitoring).