ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 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.
Enforcement
- Recall Number
- Z-0054-2015
- Event ID
- 69409
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bio-Detek, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 15, 2014
- Initiation Date
- September 16, 2014
- Classification Date
- October 8, 2014
- Termination Date
- May 3, 2016
- Address
- 525 Narragansett Park Dr, Pawtucket, RI, 02861-4323, United States
Description
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 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.
Product sterility is not assured
Lot Numbers: 1614, 1914, 2114
Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
193 cases (6/case)