Home / Recalls / Medical Devices
Bio-Detek, Inc. recalls ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Ele
Recalled September 24, 2014 · FDA recall Z-2660-2014 · Bio-Detek
Hazard
Sterility of device is not assured · FDA Class II
Units
100 cases =600 units
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 with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation 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 →