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Boston Scientific Corporation Recall 89468

Description: JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Boston Scientific Corporation Recall 89468 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0765-2022
Event ID89468
Event DescriptionJAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Product TypeDevices
DistributionWorldwide 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, Spain, Sweden, Switzerland, Unit. Arab Emir.
Quantity7115 units
Recall ReasonSterility of device is compromised due to a sterile barrier breach
Device Classification20220323
Device Code InfoLot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234
Center Classification Date20220311
Recall Initiation Date20211222
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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