Class 2 Device Recall Adelante

• Date Initiated by Firm: July 03, 2008
• Date Posted: October 29, 2008
• Recall Status: Terminated on December 09, 2008
• Recall Number: Z-0130-2009
• Recall Event ID: 49558
• 510(K)Number: K073100
• Product Classification: introducer set - Product Code DYB
• Product: Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body.
• Code Information: Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462.
• Recalling Firm/ Manufacturer: Oscor, Inc.; 3816 Desoto Blvd; Palm Harbor FL 34683
• For Additional Information Contact: 727-937-2511 Ext. 133
• Manufacturer Reason for Recall: Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
• FDA Determined Cause: Process design
• Action: Oscor notified the Direct Account by letter on 07/03/2008. Direct account was asked to return all unused Introducers back to Oscor. All returned products should be labeled with the Return Goods Product number.
• Quantity in Commerce: 396
• Distribution: Product was distributed to one direct account in MN.
• 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