Z-0977-2018 Class II Terminated
FDA device recall Z-0977-2018 was initiated by ZOLL Medical Corporation on August 4, 2017 and is designated Class II. Reason for recall: 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 Defi… The recall status is terminated (terminated August 31, 2018). Affected quantity: 3400.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 4, 2017
- Termination Date
- August 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3400
Product Description
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: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Lot Number: 2517A (Expiration date: 2019-06-24)