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Boston Scientific Corporation Recall 88369

Description: TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Boston Scientific Corporation Recall 88369 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2327-2021
Event ID88369
Event DescriptionTheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.
Quantity4980 sets
Recall ReasonPotential for leaks and loosening at the patient catheter connection
Device Classification20210825
Device Code InfoGTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Center Classification Date20210819
Recall Initiation Date20210723
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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