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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