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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 07, 2005
Date Posted February 24, 2005
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = VASCUTECH, INC.