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.
This recall has been terminated (originally issued October 9, 2014).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- September 16, 2014
- Posted
- October 9, 2014
- Terminated
- May 3, 2016
- Recall Number
- Z-0055-2015
- Quantity
- 41 singles
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility is not assured
Distribution
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Lot / Code Info
Lot Numbers: 1614, 1914, 2114
Root Cause
Material/Component Contamination
Action Taken
Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
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