FDA-Device2024-09-25Class II
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Boston Scientific Corporation
Hazard
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Sold states
US, Colombia, Philippines, Russia
Affected count
5 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3151-2024Don't want to check this manually?
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