BEUDAMED
    FDA Enforcement Class II Ongoing

    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

    Recall: Z-0708-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0708-2022
    Event ID
    89463
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Lacrimedics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    January 17, 2022
    Classification Date
    March 1, 2022
    Address
    2620 Williamson Pl Ste 113, Dupont, WA, 98327-9518, United States

    Description

    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

    Reason

    The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

    Code Info

    HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062

    Distribution

    Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK

    Quantity

    5767 units