BEUDAMED
    FDA Recall Terminated

    Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.

    Recall: Z-0842-2012 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-0842-2012
    Event Number
    60475
    Firm
    Terumo Cardiovascular Corporation
    FEI Number
    3000204839
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 28, 2010
    Posted
    January 24, 2012
    Terminated
    February 29, 2012
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.

    Reason

    Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.

    Action

    All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed "Urgent Medical Device Removal " letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.

    Distribution

    Nationwide Distribution including states of: WI, MO,and KY.

    Quantity

    16 units