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Class 2 Device Recall |
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Date Initiated by Firm |
February 07, 2005 |
Date Posted |
February 24, 2005 |
Recall Status1 |
Terminated 3 on July 25, 2005 |
Recall Number |
Z-0557-05 |
Recall Event ID |
31108 |
510(K)Number |
K992368
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Product Classification |
Catheter, Embolectomy - Product Code DXE
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Product |
LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26 |
Code Information |
Lot Numbers: SLC1184 |
Recalling Firm/ Manufacturer |
Lemaitre Vascular, Inc. 63 2nd Ave Burlington MA 01803-4413
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For Additional Information Contact |
Trent Kamke 781-221-2266 Ext. 105
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Manufacturer Reason for Recall |
Product sterility maybe compromised due to defective packaging
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FDA Determined Cause 2 |
Other |
Action |
LaMaitre notified consignees by lettter advising users to check inventory and return defective product. |
Quantity in Commerce |
100 units |
Distribution |
AL, CA, FL, IN, MD, MI,NY, TN,
FOREIGN: Germany |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DXE and Original Applicant = VASCUTECH, INC.
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