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Procedure Products, Inc. recalls U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended f
Recalled December 9, 2015 · FDA recall Z-0355-2016 · Procedure Products
Hazard
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle · FDA Class II
Units
1100 pieces
Sold at
Distributed in the states of MT and NY.
Description
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Product
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.
Manufacturer(s)
Procedure Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →