BEUDAMED
    FDA Recall Terminated

    Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.

    Recall: Z-0701-05 · Initiated December 13, 2004

    Recall

    Recall Number
    Z-0701-05
    Event Number
    30795
    Firm
    Neoprobe Corp
    FEI Number
    3009548429
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 13, 2004
    Posted
    April 13, 2005
    Terminated
    July 21, 2007
    Address
    425 Metro Pl N, Ste 300, Dublin, OH, 43017-1367

    Description

    Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.

    Reason

    The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.

    Action

    The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.

    Distribution

    Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.

    Quantity

    19 devices