Procedure Products, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0355-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 27, 2015

Date Posted: December 9, 2015

Recall Number: Z-0355-2016

Event ID: 72596

Reason for Recall:

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

Status: Terminated

Product Quantity: 1100 pieces

Code Information:

Lot 9184-A

Distribution Pattern:

Distributed in the states of MT and NY.

Voluntary or Mandated:

Voluntary: Firm initiated