DREAMTOME 49-30MM/450CM Material Number: M00584030
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 32 units of the DREAMTOME 49-30MM/450CM medical device (Material Number: M00584030, GTIN: 8714729778257) distributed worldwide, including the United States and numerous international locations. The recall was initiated because the sterility of the device is compromised due to a sterile barrier breach. The affected devices are from Lot Number 27692922.
The source document does not specify a remedy or recommended actions for consumers who may have received 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: 32 units Lot/code info: Lot Numbers: 27692922 GTIN: 8714729778257
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.