Class 2 Device Recall QuickCross Support Catheters

• Date Initiated by Firm: December 10, 2007
• Date Posted: February 05, 2008
• Recall Status: Terminated on February 08, 2008
• Recall Number: Z-0698-2008
• Recall Event ID: 45949
• Product Classification: Catheter - Product Code DQY
• Product: Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907.
• Code Information: Lot Number: 0709158
• Recalling Firm/ Manufacturer: Spectranetics Corporation; 96 Talamine Ct; Colorado Springs CO 80907-5159
• For Additional Information Contact: 719-447-2289
• Manufacturer Reason for Recall: Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters.
• Quantity in Commerce: 64
• Distribution: Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT.
• 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.