Reported Dec 9, 2015 · Terminated

U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for…

Procedure Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Procedure Products, Inc. · 1801 W Fourth Plain Blvd · Vancouver, WA · 98660-1310

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot 9184-A
Amount recalled
1100 pieces

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 1, 2016 · Data as of Sep 19, 5:20 PM UTC

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