HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling HYDRATOME RX 49-30MM/260CM devices (Material Number: M00583010) worldwide due to a sterile barrier breach that compromises the sterility of the device. The affected lot numbers are 27641142 and 28045346 (GTIN: 8714729755166). The device was distributed to the United States and numerous countries including Australia, Canada, China, France, Germany, Great Britain, Italy, Japan, and many 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: N/A Lot/code info: Lot Numbers: 27641142 28045346 GTIN: 8714729755166
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.