Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Class I - Dangerous š„ Medical Devices
Recalled: July 18, 2018 Surge Medical Sales, LLC (DBA Surge Cardiovascular) Other Medical Devices
What Should You Do?
- Check if you have this product: Lot code: 00794-030718
- 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.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Surge Medical Sales, LLC (DBA Surge Cardiovascular)
- Reason for Recall:
- The device was built with the rigid insertion stylet instead of the flexible stylet.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Product Codes/Lot Numbers:
Lot code: 00794-030718
Distribution:
Distributed in: US, SC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0068-2019