BEUDAMED
    FDA Recall Terminated

    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)

    Recall: Z-2942-2018 · Initiated July 12, 2018

    Recall

    Recall Number
    Z-2942-2018
    Event Number
    80581
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    MPB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 12, 2018
    Terminated
    July 2, 2020
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)

    Reason

    The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

    Action

    On July 12, 2018, the firm sent a Product Recall letter to its customers. Customers were provided with a full list of product codes and lot numbers and informed that those items had been recalled due to a potential for the suture wings to crack or break. Customers were informed that implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters, due to the potential for the suture wings to crack or break. Customers were instructed to return all unused recalled product to Medcomp. If product was further distributed, customers were asked to notify their sub-accounts. Contact your customer service representative for a Returned Goods Authorization (RGA) number if necessary. The phone number to call is 215-256-4201. Customers are asked to complete and return a customer response form included with the recall letter by fax (215-256-9191) or email ([email protected]).

    Distribution

    Nationwide distribution; worldwide distribution.