Z-0977-2018Class II

OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single...

Name: Z-0977-2018 OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single...
Creator: ZOLL Medical Corporation
Published: 2017-08-04
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2017-08-04 / Terminated / root cause: manufacturing process

FDA source

ZOLL Medical Corporation began a recall of OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single... on 2017-08-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0977-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-04
Posted: 2018-03-13
Terminated: 2018-08-31
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Number: 2517A (Expiration date: 2019-06-24)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code MKJ

K110742Class IIIOnestep Adult Multi-Function ElectrodeZOLL Medical Corporation / cleared 2011-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)