BEUDAMED
    FDA Recall Terminated

    Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).

    Recall: Z-2223-2010 · Initiated May 19, 2010

    Recall

    Recall Number
    Z-2223-2010
    Event Number
    55804
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    DSA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 19, 2010
    Posted
    August 13, 2010
    Terminated
    November 29, 2010
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).

    Reason

    The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.

    Action

    Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.

    Distribution

    AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.

    Quantity

    1488 units