ZOLL Adult Defibrillator Electrodes Recall for Pediatric Energy Delivery Risk
ZOLL Medical is recalling specific adult defibrillator electrodes that may cause R Series devices to deliver pediatric energy levels instead of adult levels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that results in the delivery of incorrect energy levels (pediatric instead of adult) during defibrillation. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the source does not state that any injuries or illnesses have occurred.
Plain-English summary
ZOLL Medical Corporation is recalling a portion of one lot of OneStep CPR Complete, Adult Multi Function Electrodes. The affected product includes Part Numbers 8900 0214 01 and 8900 0224 01, specifically Lot Number 2517A with an expiration date of June 24, 2019. The recall involves 3,400 units distributed nationwide in the United States and in Canada.
The recall is due to a defect where the electrodes cause the ZOLL R Series Defibrillator to deliver pediatric energy levels instead of adult energy levels. When the defective electrodes are used, the R Series defibrillator displays the message "PEDIATRIC PADS IN USE." The source text states that using the affected product with the ZOLL M Series Defibrillator poses no risk.
Trained personnel, including physicians, nurses, paramedics, emergency medical technicians, and cardiovascular laboratory technicians, should stop using the affected electrodes with ZOLL R Series Defibrillators. Users should identify the product by the part numbers and lot number provided in the recall notice.
The recalled product
- 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 Mo
- Manufacturer
- ZOLL Medical Corporation
- Affected units
- 3,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 2517A (Expiration date: 2019-06-24)
Distribution
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