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U.S. Department of Health and Human Services

Class 2 Device Recall USDN 2 Part Ultra Modified Seldinger Needles

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  Class 2 Device Recall USDN 2 Part Ultra Modified Seldinger Needles see related information
Date Initiated by Firm October 27, 2015
Date Posted December 01, 2015
Recall Status1 Terminated 3 on April 01, 2016
Recall Number Z-0355-2016
Recall Event ID 72596
510(K)Number K810859  
Product Classification Dilator, vessel, for percutaneous catheterization - Product Code DRE
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.
Code Information Lot 9184-A
Recalling Firm/
Manufacturer		 Procedure Products, Inc.
1801 W Fourth Plain Blvd
Vancouver WA 98660-1310
For Additional Information Contact Doug Rowley
360-693-1832
Manufacturer Reason
for Recall		 The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
FDA Determined
Cause 2		 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 in Commerce 1100 pieces
Distribution Distributed in the states of MT and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRE and Original Applicant = PROCEDURE PRODUCTS, INC.
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