HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 112 units of the HYDRATOME RX 49-20mm/260cm device (Material Number M00583000) due to a sterility compromise caused by a sterile barrier breach. The affected devices were distributed worldwide, including throughout the United States and in countries including Australia, Canada, China, France, Germany, Japan, Korea, and many others. The recalled units are from Lot Numbers 27852433 and 28028722, identified by GTIN 8714729755159.
The recall record does not specify what action affected consumers should take in response to 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: 112 units Lot/code info: Lot Numbers: 27852433 28028722 GTIN: 8714729755159
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.