Reported Mar 21, 2018 · Terminated
OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI:…
ZOLL Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ZOLL Medical Corporation · 269 & 271 Mill Road · Chelmsford, MA · 01824
Is this the product you have?
- OneStep CPR Complete, Adult Multi Function Electrodes
- Part Numbers8900 0214 01 (case of 8 single electrodes
- UDI10847946016279) and 8900 0224 01 (single electrode
- UDI00847946016272)
- Product UsageIntended
- UseDefibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿
- DefibrillatorsR Series, M Series. By Trained Personnel only
- IncludingPhysicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians
- Lot codes and dates
- Lot Number2517A (Expiration
- date2019-06-24)
- Amount recalled
- 3400
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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