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Boston Scientific Corporation Recall 89468

Description: HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Boston Scientific Corporation Recall 89468 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0762-2022
Event ID89468
Event DescriptionHYDRATOME RX 44-30MM/450CM Material Number: M00583070
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.
Quantity251 units
Recall ReasonSterility of device is compromised due to a sterile barrier breach
Device Classification20220323
Device Code InfoLot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227
Center Classification Date20220311
Recall Initiation Date20211222
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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