Device product
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
Z-2660-2014
Product summary
- Firm
- Bio-Detek, Inc.
- Event
- Event 69145
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 cases =600 units
- Official record key
device-enforcement:Z-2660-2014
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