DREAMTOME 44-30MM/450CM Material Number: M00584070
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 142 units of the DREAMTOME 44-30MM/450CM device (Material Number M00584070) distributed worldwide, including throughout the United States and in countries such as Canada, Australia, Japan, China, and many European nations. The recall affects Lot Numbers 27625066 and 27805561. The device is being recalled because the sterile barrier has been breached, which compromises the sterility of the device.
The record does not specify what remedy affected consumers should pursue in response to this recall.
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: 142 units Lot/code info: Lot Numbers: 27625066 27805561 GTIN: 8714729778295
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.