FDA-Device2015-12-09Class II
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Procedure Products, Inc.
Hazard
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Sold states
Distributed in the states of MT and NY.
Affected count
1100 pieces
Manufactured in
1801 W Fourth Plain Blvd, Vancouver, WA, United States
Products
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0355-2016Don't want to check this manually?
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