BEUDAMED
    FDA Recall Terminated

    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.

    Recall: Z-3179-2011 · Initiated July 25, 2011

    Recall

    Recall Number
    Z-3179-2011
    Event Number
    59656
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    KQT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 25, 2011
    Posted
    September 9, 2011
    Terminated
    December 14, 2011
    Address
    1591 Scottsdale Court, Elgin, IL, 60123-9340

    Description

    Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.

    Reason

    The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump.

    Action

    The firm, Northgate Technologies, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated August 18, 2011 to the Olympus America customers who ordered the Aspiration Tubing Set, 72-00114-0. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall for subsequent return to Northgate Technologies; if they further distributed this product, they were to identify and notify their customers of the recall, and complete and return the enclosed Return Response Form via fax to (847) 608-9405 or mail to: Northgate Technologies Inc., 1591 Scottsdale Court, Elgin, IL 60123. If you have any questions, please call (224) 856-2222 or e-mail to: [email protected].

    Distribution

    Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.

    Quantity

    10,680 sets