Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
FDA Recall #Z-0752-2022 — Class II — December 22, 2021
Product Description
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Reason for Recall
Sterility of device is compromised due to a sterile barrier breach
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1811 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Code Information
Lot Numbers: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated