Class 2 Device Recall Custom Kit

• Date Initiated by Firm: April 15, 2008
• Date Posted: September 04, 2008
• Recall Status: Terminated on September 03, 2008
• Recall Number: Z-1699-2008
• Recall Event ID: 47891
• Product Classification: Convenience Kit - Product Code DQO
• Product: Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
• Code Information: Lot Number F594282
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4408 Ext. 349
• Manufacturer Reason for Recall: Convenience kits may be non-sterile due to inadequate package sealing.
• FDA Determined Cause: Process control
• Action: Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.
• Quantity in Commerce: 10 kits
• Distribution: MO. Foreign distribution to Japan. No military or government distribution.
• 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.