DREAMTOME 49-30MM/260CM Material Number: M00584010
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 472 units of the DREAMTOME 49-30MM/260CM medical device (Material Number: M00584010) worldwide. The recall was initiated because the sterility of the device is compromised due to a sterile barrier breach. The affected devices were distributed to the United States and 30 other countries, including Australia, Canada, China, France, Germany, Japan, New Zealand, and the United Kingdom. The recalled units are identified by lot numbers 27566790, 27641143, and 27852432.
The record does not specify a remedy or instructions for what consumers should do 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: 472 units Lot/code info: Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.