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-1445-2017
• Recall Event ID: 76476
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53
• Code Information: Lot Number/Ex p. Date: RED1747 2018-09 RED1754 2018-12 RED1763 2019-03 RED1770 2019-05
• 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: 250
• 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.