JAGTOME RX 44-20-260-035 Material Number: M00573040
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 3,578 units of the JAGTOME RX 44-20-260-035 medical device (Material Number: M00573040) distributed worldwide, including across the United States and 32 other countries. The recall was initiated because the sterile barrier of the device has been compromised, which affects the sterility of the product. The affected devices are identified by specific lot numbers ranging from 27465198 to 28289452, with a GTIN of 8714729776659.
Consumers who may have received one of the affected devices should check their lot number against the list provided in the recall notice. The source document does not specify what remedy is available to 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: 3578 units Lot/code info: Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.