Class 2 Device Recall Scanlan MobinUddin Vein Holder

• Date Initiated by Firm: February 19, 2007
• Date Posted: April 03, 2007
• Recall Status: Terminated on June 27, 2007
• Recall Number: Z-0701-2007
• Recall Event ID: 37596
• Product Classification: Vein Holder - Product Code KDC
• Product: SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.
• Code Information: Lot AZ115806.
• FEI Number: 2126670
• Recalling Firm/ Manufacturer: Scanlan International Inc; 1 Scanlan Plz; Saint Paul MN 55107-1639
• Manufacturer Reason for Recall: Incorrectly assembled by manufacturer
• FDA Determined Cause: Other
• Action: The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.
• Quantity in Commerce: 35 units domestically ( 70 units to OUS)
• Distribution: Worldwide distribution --- USA including states of IN, MO and country of Japan
• 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.