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.
Recall
- Recall Number
- Z-0355-2016
- Event Number
- 72596
- Firm
- Procedure Products, Inc.
- FEI Number
- 3020778
- Product Code
- DRE
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 27, 2015
- Posted
- December 1, 2015
- Terminated
- April 1, 2016
- Address
- 1801 W Fourth Plain Blvd, Vancouver, WA, 98660-1310
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.
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
The firm sent the Urgent Medical Device Recall letter to their consignees via email on 10/27/15. Customers with questions can call Doug Rowley at 360-693-1832 or send email to [email protected]
Distributed in the states of MT and NY.
1100 pieces