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Bio-Detek, Inc. recalls ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Elect
Recalled October 15, 2014 · FDA recall Z-0053-2015 · Bio-Detek
Hazard
Product sterility is not assured · FDA Class II
Units
18 singles
Sold at
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Description
Product sterility is not assured
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Manufacturer(s)
Bio-Detek, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →