BEUDAMED
    FDA Recall Terminated

    Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.

    Recall: Z-1140-2010 · Initiated February 1, 2010

    Recall

    Recall Number
    Z-1140-2010
    Event Number
    54623
    Firm
    Centurion Medical Products
    FEI Number
    1824619
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2010
    Posted
    March 15, 2010
    Terminated
    November 8, 2010
    Address
    301 Catrell Dr, Howell, MI, 48843-1703

    Description

    Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit.

    Reason

    A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles.

    Action

    An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or on the MedWatch website at www.fda.gov/medwatch. The customers were also instructed to check the lot numbers of products in inventory to determine if they have products affected by this withdrawal and complete and return the enclosed Customer Response Form by fax or email. Direct all inquiries to: EXEL International Customer Service 727-827-1922 ext. 0 Monday through Friday 9am-5pm EST or E-mail [email protected]

    Distribution

    USA only

    Quantity

    880 kits