ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Lot Codes
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ConMed Corporation
- Reason for Recall:
- Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Product Codes/Lot Numbers:
All Lot Codes
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0456-2015
Related Recalls
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used