Class 2 Device Recall GALT MEDICAL GUIDEWIRE

• Date Initiated by Firm: April 11, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on October 28, 2008
• Recall Number: Z-1909-2008
• Recall Event ID: 47856
• 510(K)Number: K031916
• Product Classification: Catheter Guide Wire - Product Code DQX
• Product: CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
• Code Information: Lot number MAPA870
• Recalling Firm/ Manufacturer: Medical Components, Inc dba MedComp; 1499 Delp Dr; Harleysville PA 19438-2936
• For Additional Information Contact: Susan Smith, RN BSN; 215-256-4201
• Manufacturer Reason for Recall: kit contains incorrect component
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
• Quantity in Commerce: 100 units
• Distribution: The products were shipped to customers in PA and TX.
• 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 = DQX