BEUDAMED
    FDA Recall Terminated

    Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) lonq Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.

    Recall: Z-1306-2012 · Initiated February 23, 2012

    Recall

    Recall Number
    Z-1306-2012
    Event Number
    60718
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2012
    Posted
    March 23, 2012
    Terminated
    April 3, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) lonq Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.

    Reason

    During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.

    Action

    Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to [email protected] and call Terumo CVS Customer Service for a Returned Goods Authorization (RGA) number. For questions call Terumo CVS Customer Service at 1-800-521-2818.

    Distribution

    USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.

    Quantity

    188,282 Cannulae and 248 Custom Tubing Packs