Z-0055-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2014
- Initiation Date
- September 16, 2014
- Termination Date
- May 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 singles
Product Description
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.
Reason for Recall
Product sterility is not assured
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Code Information
Lot Numbers: 1614, 1914, 2114