Device product
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.
Z-2659-2014
Product summary
- Firm
- Bio-Detek, Inc.
- Event
- Event 69145
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 each
- Official record key
device-enforcement:Z-2659-2014
Official wording
Reason: Sterility of device is not assured
Code information: Lot Number: 2314
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Derived failure modes
-
Unknown
Sterility of device is not assured