Device product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 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.
Z-0052-2015
Product summary
- Firm
- Bio-Detek, Inc.
- Event
- Event 69409
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 cases (6/case)
- Official record key
device-enforcement:Z-0052-2015
Official wording
Reason: Product sterility is not assured
Code information: Lot Numbers: 1614, 1814, 1914
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Derived failure modes
-
Sterility assurance
sterility is not assured