ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.
Enforcement
- Recall Number
- Z-2659-2014
- Event ID
- 69145
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bio-Detek, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 24, 2014
- Initiation Date
- August 26, 2014
- Classification Date
- September 17, 2014
- Termination Date
- May 3, 2016
- Address
- 525 Narragansett Park Dr, N/A, Pawtucket, RI, 02861-4323, United States
Description
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.
Sterility of device is not assured
Lot Number: 2314
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
12 each