LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial

FDA device recall Z-0382-2016 · posted 2015-12-04 · Terminated

Recall details

Recalling firm

LeMaitre Vascular, Inc.

Reason for recall

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

DXE

Quantity affected

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, Latv

Date initiated

2015-10-21

Date posted

2015-12-04

Date terminated

2019-07-12

Location

Burlington, MA

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