HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 251 units of HYDRATOME RX 44-30MM/450CM (Material Number M00583070) due to a sterile barrier breach that compromises the device's sterility. The affected units were distributed worldwide, including throughout the United States and in countries including Australia, Canada, China, France, Germany, Japan, and many others. The recall involves three lot numbers: 27556713, 27684748, and 27949033.
The source document 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: 251 units Lot/code info: Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.