Class 2 Device Recall

• Date Initiated by Firm: February 07, 2005
• Date Posted: February 24, 2005
• Recall Status: Terminated on July 25, 2005
• Recall Number: Z-0560-05
• Recall Event ID: 31108
• 510(K)Number: K992368
• Product Classification: Catheter, Embolectomy - Product Code DXE
• Product: LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex Model: 1601-58
• Code Information: Lot Numbers: SLC1193, SLC1209
• Recalling Firm/ Manufacturer: Lemaitre Vascular, Inc.; 63 2nd Ave; Burlington MA 01803-4413
• For Additional Information Contact: Trent Kamke; 781-221-2266 Ext. 105
• Manufacturer Reason for Recall: Product sterility maybe compromised due to defective packaging
• FDA Determined Cause: Other
• Action: LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
• Quantity in Commerce: 713 units
• Distribution: AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
• 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 = DXE