BEUDAMED
    FDA Recall Terminated

    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings

    Recall: Z-1036-2016 · Initiated February 3, 2016

    Recall

    Recall Number
    Z-1036-2016
    Event Number
    73237
    Firm
    Medical Action Industries Inc
    FEI Number
    1030451
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2016
    Terminated
    June 28, 2016
    Address
    25 Heywood Rd, Arden, NC, 28704-9302

    Description

    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings

    Reason

    Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

    Action

    Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting [email protected] . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.

    Distribution

    Nationwide distribution to MO, NE and TX .

    Quantity

    9 cases (180 kits)