BEUDAMED
    FDA Recall Terminated

    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

    Recall: Z-2458-2015 · Initiated August 3, 2015

    Recall

    Recall Number
    Z-2458-2015
    Event Number
    71889
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    OFF
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 3, 2015
    Posted
    August 25, 2015
    Terminated
    January 5, 2017
    Address
    1 Medline Pl, Mundelein, IL, 60060-4485

    Description

    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

    Reason

    The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.

    Action

    Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129.

    Distribution

    US including PA

    Quantity

    320 units for lot 14DB9277 & 320 units for lot 14PB2878