Z-2350-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- June 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 US, 39 OUS
Product Description
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
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.
Distribution Pattern
Domestic distribution nationwide.
Code Information
UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027