Recall Z-2659-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Bio-Detek, Inc.
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environm
| Date | Sep 17, 2014 (initiated Aug 26, 2014) |
| Status | Terminated |
| Reason | Sterility of device is not assured |
| Root cause | Process control |
| Action | 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 |
| Quantity | 12 each |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, 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 |