Class 2 Device Recall LeMaitre

• Date Initiated by Firm: February 07, 2017
• Create Date: March 13, 2017
• Recall Status: Terminated on September 20, 2019
• Recall Number: Z-1447-2017
• Recall Event ID: 76476
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
• Code Information: Lot Number/Exp. Date: RST2404 2018-012 RST2416 2019-02 RST2424 2019-03 RST2426 2019-03 RST2442 2019-07
• FEI Number: 1220948
• Recalling Firm/ Manufacturer: LeMaitre Vascular, Inc.; 63 2nd Ave; Burlington MA 01803-4413
• For Additional Information Contact: 781-221-2266
• Manufacturer Reason for Recall: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
• FDA Determined Cause: Labeling design
• Action: LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.
• Quantity in Commerce: 403
• Distribution: Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
• 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.