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Boston Scientific Corporation Recall 89468

Description: JAGTOME RX 44-30-260-035 Material Number: M00573060

Boston Scientific Corporation Recall 89468 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0775-2022
Event ID89468
Event DescriptionJAGTOME RX 44-30-260-035 Material Number: M00573060
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.
Quantity2209 units
Recall ReasonSterility of device is compromised due to a sterile barrier breach
Device Classification20220323
Device Code InfoLot Numbers: Batch 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673
Center Classification Date20220311
Recall Initiation Date20211222
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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