BEUDAMED
    FDA Enforcement Class II Terminated

    Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.

    Recall: Z-1443-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1443-2015
    Event ID
    70822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2015
    Initiation Date
    June 24, 2014
    Classification Date
    April 13, 2015
    Termination Date
    November 5, 2015
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.

    Reason

    Potential for inadvertent scalpel stick injury involving the safety scalpel.

    Code Info

    Lot numbers: 1174108,1174108,1174108D,1174108D,1174108D,1174108D,1174108D,1174108D,1175108,1175108,1175108,1175108,1175108,1194108,1194108,1194108,1194108D,1194108D,1194108D,1194108D,1194108D,1194118,1194118,1194118,1194118,1194118,1275108,1275108,1275108,1275108,1275108D,1275108D,1275108D,1275108D,1275108D,1295108,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108D,1295108FD,1295108FD,1295118,1295118,1295118,1295118,1295118,1385108Q,1385108QD,1385108QD,1385108QD,1385108QD,1386108,1386108D,1386108D,1395108QD,1395108QD,1396118,2194108,2194108,2295108,3154108,3154108,3174108,3174108,3174108,3174108,3174108d,3175108,3194108,3194108D,3255108,3255108,3255108,3255108,3274108,3275108,3275108d,3275108d,3295108,3295108,3295108,3295108d,3295108FD,3295108FD,3385108Q,3385108QD,3385108QD,3385108QD,3386108,3386108,3386108,3386108d,3395108Q,3395108QD,3395108QD,3396108,3396118,4154108,4154108,4154108,4154108D,4154108D,4154108D,4154108D,4154108D,4154108D,5575240,5605150,5605150,5605150,5605200,5605200,5605200,5605200,5605240,5605240,5605300,5605300,5615150,5615150,5615150,5615150,5615150,5615200,5615200,5615200,5625150,5625150,5625240,5655200,5755200,5766150,5766150,6174108,6194108,6194108,6194118,6194118,6295108,6295108,9173108,9173108D,9174108,9174108,9194108,9194108,9194108,9194108D,9275108d,9275108d,9275108f,9275108f,9275108f,9295108fd,9295108fd,9385108Q,9385108Q,9385108QD,9385108QD,9385108QD,9395108QD,9395108QD,9395108QD,9395118Q,9717308,

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    51,025 units