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Boston Scientific Corporation Recall 89468

Description: HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Boston Scientific Corporation Recall 89468 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0759-2022
Event ID89468
Event DescriptionHYDRATOME RX 44-20MM/260CM Material Number: M00583040
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.
Quantity7695 units
Recall ReasonSterility of device is compromised due to a sterile barrier breach
Device Classification20220323
Device Code InfoLot Numbers: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197
Center Classification Date20220311
Recall Initiation Date20211222
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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