DREAMTOME 44-30MM/260CM Material Number: M00584050
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 12,067 units of the DREAMTOME 44-30MM/260CM medical device (Material Number: M00584050) due to a sterile barrier breach that compromises the device's sterility. The affected devices were distributed worldwide, including throughout the United States and 32 other countries, and are identified by 22 specific lot numbers ranging from 27453804 to 28054381.
The recall notice does not specify a remedy for consumers who may have 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: 12067 units Lot/code info: Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.