FDA Device recall Z-0977-2018
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 89…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 89… by Zoll Medical, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0977-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-04 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zoll Medical |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot Number: 2517A (Expiration date: 2019-06-24) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2018%22
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