FDAFDA · Food and drugs·Recall number Z-0355-2016
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.
Published December 9, 2015 · Recall initiated: October 27, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Procedure Products, Inc.
- Distributor
- Distributed in the states of MT and NY.
- Lot
- Lot 9184-A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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