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U.S. Department of Health and Human Services

Class 2 Device Recall LeMaitre

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  Class 2 Device Recall LeMaitre see related information
Date Initiated by Firm October 21, 2015
Date Posted December 04, 2015
Recall Status1 Terminated 3 on July 12, 2019
Recall Number Z-0385-2016
Recall Event ID 72534
510(K)Number K022145  
Product Classification Catheter, embolectomy - Product Code DXE
Product LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68.
Indicated for the removal of arterial emboli and thrombi.
Code Information Lot Number: OTW3099¿ 
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Salva Kozin
781-221-2266 Ext. 108
Manufacturer Reason
for Recall		 Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.
Quantity in Commerce 4315 total
Distribution Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
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 = LEMAITRE VASCULAR, INC.
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