BEUDAMED
    FDA Enforcement Class II Terminated

    PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

    Recall: Z-2129-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2129-2017
    Event ID
    77081
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    April 21, 2017
    Classification Date
    May 22, 2017
    Termination Date
    January 27, 2020
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

    Reason

    Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

    Code Info

    Product Code: PE102, Lot numbers: 02A1101041, 02B1102552, 02C1001258, 02C1003795, 02C1101253, 02C1104114, 02D0802670, 02D0803968, 02D1000682, 02D1002136, 02D1101334, 02E1001502, 02E1100384, 02F0800281, 02F1000667, 02F1002368, 02F1101766, 02F1102607, 02F1103754, 02G1000322, 02G1001538, 02H0801670, 02H0803375, 02H1000732, 02H1103023, 02H1103940, 02J1000236, 02J1001515, 02J1002609, 02J1003237, 02J1101139, 02J1102143, 02K1000270, 02K1001993, 02K1100519,02K1103124, 02K1301613, 02L0701463, 02L0701958, 02L0702675, 02L1000763, 02M0700783, 02M1001319, 74A1600225, 74A1600226, 74B1601947, 74B1601948, 74D1600917, 74F1401859, 74F1502294, 74F1502573, 74F1602371, 74H1601152, 74J1601641, 74K1501590 & 74L1500555.

    Distribution

    Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.

    Quantity

    19,043 units in total