FDA Device recall Z-3151-2024
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300 by Boston Scientific, citing there is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3151-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-18 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | GTIN/UDI 0871472904856, Lot # 33751204, exp. 04/03/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3151-2024%22
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