BEUDAMED
    FDA Recall Terminated

    14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

    Recall: Z-1149-2019 · Initiated March 13, 2019

    Recall

    Recall Number
    Z-1149-2019
    Event Number
    82415
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    LFJ
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    March 13, 2019
    Terminated
    March 5, 2024
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

    Reason

    Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

    Action

    On March 13, 2019, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed that the kits contain a 15F "non-valved" peelable introducer despite the label indicating that the kit is packaged with a "valved" introducer. Customers were asked to do the following: 1. Immediately examine your inventory and quarantine product subject to recall. 2. If you have further distributed this product, please identify your customers and immediately notify them of the recall. 3. Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization (RGA) number if you have product to return. The phone number to call is 215-256-4201. 4.Complete and return the Medical Device Recall Return Response Form. The form can be returned by fax (215-256-9191) or email ([email protected]). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: [email protected]

    Distribution

    Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

    Quantity

    6830