Recall Z-0055-2015 ยท MKJ Automated External Defibrillators (Non-Wearable)
Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 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 11137-2:201
| Date | Oct 9, 2014 (initiated Sep 16, 2014) |
| Status | Terminated |
| Reason | Product sterility is not assured |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 41 singles |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943698 | STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES Zoll Medical Corp, Dec 28, 1994 |