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Boston Scientific Corporation Recall 92072

Description: WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Boston Scientific Corporation Recall 92072 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1592-2023
Event ID92072
Event DescriptionWATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Product TypeDevices
DistributionWorldwide
Quantity1300 units
Recall ReasonThe firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Device Classification20230524
Device Code InfoGTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565
Center Classification Date20230516
Recall Initiation Date20230405
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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