Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Product Codes/Lot Numbers:
UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2350-2024
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