BEUDAMED
    FDA Recall Terminated

    Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

    Recall: Z-0103-06 · Initiated September 15, 2005

    Recall

    Recall Number
    Z-0103-06
    Event Number
    33789
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2005
    Posted
    October 28, 2005
    Terminated
    November 22, 2005
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

    Reason

    The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F

    Action

    On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.

    Distribution

    The products were shipped to distributors in OH and MO.

    Quantity

    10 units