FDAFDA · Food and drugs·Recall number Z-0055-2015
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 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.
Published October 15, 2014 · Recall initiated: September 16, 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
Product sterility is not assured
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Detek, Inc.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
- Lot
- Lot Numbers: 1614, 1914, 2114
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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