Reported Jul 24, 2024 · Ongoing
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
- Lot codes and dates
- UDI-DI (GTIN) 08714729444749
- Lot 33280747 Expiration Date
January 232027
- Amount recalled
- 256 US, 39 OUS
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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