BEUDAMED
    FDA Enforcement Class II Completed

    PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    Recall: Z-2912-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2912-2020
    Event ID
    86131
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2020
    Initiation Date
    July 29, 2020
    Classification Date
    August 28, 2020
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    Reason

    A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

    Code Info

    Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092 Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125

    Distribution

    US Nationwide distribution

    Quantity

    7119625 total