Recall Z-0053-2015
Bio-Detek, Inc. · initiated September 16, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 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.
Codes / lots: Lot Numbers: 1614, 1814
Reason for recall
Product sterility is not assured
FDA-determined cause: Material/Component Contamination
Action taken
Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
Details
- Recall number
- Z-0053-2015
- Initiated
- September 16, 2014
- Posted by FDA
- October 9, 2014
- Terminated
- May 3, 2016
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 18 singles
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
- Recalling firm
- Bio-Detek, Inc., Pawtucket, RI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0052-2015 Class II | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product…Product sterility is not assured | 09/16/2014Terminated |
| Z-0054-2015 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part…Product sterility is not assured | 09/16/2014Terminated |
| Z-0055-2015 Class II | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1…Product sterility is not assured | 09/16/2014Terminated |