Class 2 Device Recall Gish Connector with Luer fitting

• Date Initiated by Firm: September 14, 2012
• Date Posted: October 25, 2012
• Recall Status: Terminated on April 23, 2013
• Recall Number: Z-0157-2013
• Recall Event ID: 63361
• 510(K)Number: K833322
• Product Classification: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
• Product: Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile.
• Code Information: Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15.
• Recalling Firm/ Manufacturer: Sorin Group USA, Inc.; 14401 W 65th Way; Arvada CO 80004
• For Additional Information Contact: Jack Ellison; 303-467-6306
• Manufacturer Reason for Recall: Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.
• FDA Determined Cause: Process control
• Action: Sorin Group USA, Inc. sent a Product Recall letter to all affected customers by certified mail on September 14, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to discontinue use of the affected product, return all unused product to the firm and to complete and return a Response Form via fax or email. For further questions, contact the firm at 1-800-650-2623.
• Quantity in Commerce: 1,640 units
• Distribution: US Nationwide Distribution in the states of: AL, AR, CA, CO, CT, FL, IL, MI, MN, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
• 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 = DTL