BEUDAMED
    FDA Recall Terminated

    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

    Recall: Z-0390-2016 · Initiated October 21, 2015

    Recall

    Recall Number
    Z-0390-2016
    Event Number
    72534
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 21, 2015
    Posted
    December 4, 2015
    Terminated
    July 12, 2019
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

    Reason

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

    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.

    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.

    Quantity

    4315 total