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Boston Scientific Corporation Recall 95186

Description: VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.

Boston Scientific Corporation Recall 95186 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-3151-2024
Event ID95186
Event DescriptionVTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Product TypeDevices
DistributionUS, Colombia, Philippines, Russia
Quantity5 units
Recall ReasonThere is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Device Classification20240925
Device Code InfoGTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027
Center Classification Date20240913
Recall Initiation Date20240718
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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