DREAMTOME 49-20MM/260CM Material Number: M00584000
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 982 units of the DREAMTOME 49-20MM/260CM device (Material Number: M00584000) due to a sterile barrier breach that compromises the sterility of the device. The affected units were distributed worldwide, including throughout the United States and in countries such as Australia, Canada, China, France, Germany, Japan, and many others. The recall involves six specific lot numbers: 27566791, 27604633, 27690970, 27804364, 27951185, and 28028721.
The source document does not specify what remedy or action affected consumers should take regarding 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: 982 units Lot/code info: Lot Numbers: 27566791 27604633 27690970 27802364 27951185 28028721 GTIN: 8714729778226
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.