FDA Medical Device Recalls (openFDA)
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: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.
- Recall number
- Z-0977-2018
- Recalling firm
- ZOLL Medical Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-08-04
- Posted
- not on file
- Terminated
- 2018-08-31
- 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 attached form and return to ZOLL for replacement electrodes. ZOLL will be replacing the effected lot of the electrodes with properly configured electrodes. For questions contact technical support at 1-800-348-9011 or 1-978-421-9460.
- 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.
- Lot, serial or model codes
- Lot Number: 2517A (Expiration date: 2019-06-24)
- 510(k) numbers
- ["K110742"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1220908
- Firm city
- Chelmsford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28