FDAFDA · Food and drugs·Recall number Z-2350-2024
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Published July 24, 2024 · Recall initiated: June 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Domestic distribution nationwide.
- Lot
- UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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