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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 LeMaitresee related information
Date Initiated by FirmOctober 21, 2015
Date PostedDecember 04, 2015
Recall Status1 Terminated 3 on July 12, 2019
Recall NumberZ-0387-2016
Recall Event ID 72534
510(K)NumberK992368 
Product Classification Catheter, embolectomy - Product Code DXE
ProductLeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Code Information Lot Number: SLC3636 SLC3636 (sample) SLC3636¿SLC3668 SLC3668¿SLC3669¿SLC3654¿ SLC3670¿   
Recalling Firm/
Manufacturer
LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information ContactSalva 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
ActionConsignees 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 Commerce4315 total
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DXE
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