FDAFDA · Food and drugs·Recall number Z-2660-2014
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.
Published September 24, 2014 · Recall initiated: August 26, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility of device is not assured
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Detek, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
- Lot
- Lot Number: 2314
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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