BEUDAMED
    FDA Enforcement Class I Ongoing

    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

    Recall: Z-0073-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0073-2023
    Event ID
    90816
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    August 29, 2022
    Classification Date
    October 14, 2022
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

    Reason

    Incidents of device splitting or detaching during use

    Code Info

    a) 19261, UDI: (01)04026704388486(17)260128(10)KMH21B0193, (01)04026704388486(17)251028(10)KMH20L0234, (01)04026704388486(17)260828(10)KMH21J0246, (01)04026704388486(17)261028(10)KMH21L0294, (01)04026704388486(17)261228(10)KMH22A0230; b) 19272, UDI: (01)04026704388509(17)260428(10)KMZ21E0613, (01)04026704388509(17)260528(10)KMZ21F0939

    Distribution

    US nationwide distribution

    Quantity

    7 units