Z-2660-2014 Class II Terminated
FDA device recall Z-2660-2014 was initiated by Bio-Detek, Inc. on August 26, 2014 and is designated Class II. Reason for recall: Sterility of device is not assured The recall status is terminated (terminated May 3, 2016). Affected quantity: 100 cases =600 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- August 26, 2014
- Termination Date
- May 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 cases =600 units
Product Description
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.
Reason for Recall
Sterility of device is not assured
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Code Information
Lot Number: 2314