Class 3 Device Recall Kendall Tyco/healthcare

• Date Initiated by Firm: December 02, 2003
• Date Posted: December 17, 2003
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0234-04
• Recall Event ID: 27842
• 510(K)Number: K030209
• Product Classification: Catheter, Hemodialysis, Non-Implanted - Product Code MPB
• Product: Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm ; For hemodialysis, apheresis, and infusion; Reference: 8888-135195
• Code Information: Lot Number: 140774
• Recalling Firm/ Manufacturer: Kendall Healthcare Products Co; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: David Olson; 508-261-8530
• Manufacturer Reason for Recall: Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm
• FDA Determined Cause: Other
• Action: Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.
• Quantity in Commerce: 10
• Distribution: IL, MA, OH, TN, TX, VA
• 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 = MPB and Original Applicant = THE KENDALL COMPANY