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Bio-Detek, Inc. recalls ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connecti
Recalled September 24, 2014 · FDA recall Z-2658-2014 · Bio-Detek
Hazard
Sterility of device is not assured · FDA Class II
Units
198 cases
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Description
Sterility of device is not assured
Product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.
Manufacturer(s)
Bio-Detek, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →