HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 7,695 units of the HYDRATOME RX 44-20MM/260CM medical device (Material Number M00583040) worldwide due to a sterile barrier breach that compromises the sterility of the device. The affected units were distributed across the United States and numerous countries including Australia, Canada, Japan, China, and many European nations. The recall affects specific lot numbers ranging from 27439836 through 28043447.
The recalled devices are identified by GTIN 8714729755197 and the specific lot numbers listed in the recall notice. The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 7695 units Lot/code info: Lot Numbers: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.