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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-3151-2024 |
Event ID | 95186 |
Event Description | VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract. |
Product Type | Devices |
Distribution | US, Colombia, Philippines, Russia |
Quantity | 5 units |
Recall Reason | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
Device Classification | 20240925 |
Device Code Info | GTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027 |
Center Classification Date | 20240913 |
Recall Initiation Date | 20240718 |
Recalling Firm | Boston Scientific Corporation |
Initial Notification | Letter |
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