HYDRATOME RX 44-30MM/260CM Material Number: M00583050
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation recalled 3,371 units of the HYDRATOME RX 44-30MM/260CM medical device (Material Number: M00583050) due to a sterility compromise caused by a sterile barrier breach. The affected lot numbers are 27503545, 27539248, 27622371, 27830206, 27836999, 27892995, and 27940790. The device was distributed worldwide, including throughout the United States and in countries including Australia, Austria, Belgium, Canada, China, France, Germany, Great Britain, Italy, Japan, Korea, Netherlands, New Zealand, Poland, and many others.
The record does not specify a remedy or corrective action for affected consumers.
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: 3371 units Lot/code info: Lot Numbers: 27503545 27539248 27622371 27830206 27836999 27892995 27940790 GTIN: 8714729755203
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.