Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling the Dreamtome RX Cannulating Sphincterotome (model DREAMTOME 44-20MM/260CM, material number M00584040) due to sterility compromise caused by a sterile barrier breach. The recall affects 21,309 units distributed worldwide, including throughout the United States and in countries including Australia, Canada, France, Germany, Great Britain, Japan, and South Africa, among many others.
The affected devices are identified by specific batch numbers ranging from 27446479 to 28296779. The product recall record does not specify a remedy or recommended action for consumers who may have received affected units.
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: 21309 units Lot/code info: Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616517 27674795 27679150 27681372 27682823 27710650 27715915 27740170 27742966 27746783 27747640 27770749 27779090 27781488 27784284 27806906 27808089 27813903 27818805 27869283 27872956 27955178 27958586 27965294 28021413 28054973 28118052 28296777 28296779 GTIN: 8714729778264
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.