Class 2 Device Recall Introducer, Catheter

• Date Initiated by Firm: September 13, 2005
• Date Posted: January 06, 2006
• Recall Status: Terminated on July 08, 2012
• Recall Number: Z-0345-06
• Recall Event ID: 34123
• 510(K)Number: K871153
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant)
• Code Information: BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
• Recalling Firm/ Manufacturer: Oscor Inc.; 3816 De Soto Blvd; Palm Harbor FL 34683-1618
• Manufacturer Reason for Recall: Sheath size is larger than dilator size causing insertion difficulties.
• FDA Determined Cause: Other
• Action: The firm will issue a recall letter to its consignees informing them of the recall. The letter will ask the consignees to return the devices from affected lot numbers for replacement. The returned products will be individually inspected.
• Quantity in Commerce: 6985
• Distribution: Distributed throughout the United States and to several foreign countries including China, Japan, Germany and the Phillippines.
• 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 = DYB and Original Applicant = ANGEION CORP.