Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 4773676, 4776428 and 4780110
- 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:
- Angiodynamics
- Reason for Recall:
- Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Product Codes/Lot Numbers:
Lot No. 4773676, 4776428 and 4780110
Distribution:
Distributed in: US, AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1143-2015
Related Recalls
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.