FDAAugust 4, 2017device
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....
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
zoll medicalzoll
UPCs
1084794601627900847946016272
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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