DREAMTOME 49-20MM/450CM Material Number: M00584020
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 15 units of the DREAMTOME 49-20MM/450CM device (Material Number M00584020, Lot Number 27802363) due to a sterile barrier breach that compromises the device's sterility. The affected devices were distributed worldwide, including throughout the United States and in countries including Australia, Canada, China, France, Germany, Japan, Korea, the Netherlands, and others.
The recall record does not specify a remedy or what affected consumers should do.
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: 15 units Lot/code info: Lot Numbers: 27802363 GTIN: 8714729778240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.