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.
This recall has been terminated (originally issued September 17, 2014).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- August 26, 2014
- Posted
- September 17, 2014
- Terminated
- May 3, 2016
- Recall Number
- Z-2660-2014
- Quantity
- 100 cases =600 units
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility of device is not assured
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Lot / Code Info
Lot Number: 2314
Root Cause
Process control
Action Taken
BioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.