BEUDAMED
    FDA Recall Terminated

    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

    Recall: Z-1048-2014 · Initiated August 14, 2013

    Recall

    Recall Number
    Z-1048-2014
    Event Number
    66080
    Firm
    Medline Industries, Inc.
    FEI Number
    3000717925
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 14, 2013
    Posted
    February 21, 2014
    Terminated
    December 19, 2017
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

    Reason

    Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.

    Action

    The firm, Medline Industries, Inc., sent a "RECALL IMMEDIATE ACTION REQUIRED" letter dated August 14, 2013, to its direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their stocks for inventory of the affected products, quarantine any affected products, return the product using the enclosed shipping slips for credit-If additional stickers are needed, please call 866-359-1704, and complete and return the enclosed FAX-BACK VERIFICATION FORM listing the quantity of affected product(s) on hand via fax to Medline at 866-767-1290. If you have any questions, please contact 866-359-1704.

    Distribution

    Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

    Quantity

    160 units