Recall Z-0977-2018 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physician
| Date | Aug 4, 2017 |
| Status | Terminated |
| Reason | A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk. |
| Root cause | Process control |
| Action | Zoll sent an Urgent Device Correction letter dated August 4, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The following actions should be taken until the affected electrodes are removed from use: 1. Alert staff to the possibility of this occurrence. 2. Instruct staff to inspect the lot code on the electrode package and remove affected lot 2517A from use. 3. Inform users that if they encounter this situation in the process of defibrillating an adult patient, they should set the defibrillator energy level manually. 4. Complete the att |
| Quantity | 3400 |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and in the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE ZOLL Medical Corporation, Apr 13, 2011 |