U-SDN 2 Part Ultra Modified Seldinger Needles recalled over sterility concerns

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 for…

Recall number

Z-0355-2016

FDA classification

Class II

Brand / firm

Procedure Products, Inc.

Sold / distributed

Distributed in the states of MT and NY.

Why it was recalled

The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.