Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 1,811 units of the Dreamtome Cannulating Sphincterotome (Model 44-20MM/450CM, Material Number M00584060) across worldwide distribution including the United States and numerous international markets. The recall was initiated because the sterility of the device is compromised due to a sterile barrier breach. The affected devices are identified by twelve specific lot numbers ranging from 27463326 to 28058938.
The source document does not specify a remedy or recommended action for consumers who may have obtained this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Sterility of device is compromised due to a sterile barrier breach
Reason for recall: Sterility of device is compromised due to a sterile barrier breach 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 Quantity: 1811 units Lot/code info: Lot Numbers: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.