FDA Enforcement
Class II
Ongoing
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Recall: Z-3151-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3151-2024
- Event ID
- 95186
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- July 18, 2024
- Classification Date
- September 13, 2024
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565, United States
Description
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Reason
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code Info
GTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027
Distribution
US, Colombia, Philippines, Russia
Quantity
5 units