FDA Medical Device Recalls (openFDA)
Procedure Products, Inc.: 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 number
- Z-0355-2016
- Recalling firm
- Procedure Products, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-10-27
- Posted
- 2015-12-01
- Terminated
- 2016-04-01
- Reason
- The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
- Root cause
- Nonconforming Material/Component
- Action
- 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 doug@procedureproducts.com
- Quantity
- 1100 pieces
- Distribution
- Distributed in the states of MT and NY.
- Lot, serial or model codes
- Lot 9184-A
- 510(k) numbers
- ["K810859"]
- PMA numbers
- not on file
- Product code
- DRE
- Firm FEI
- 3020778
- Firm city
- Vancouver
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28