BEUDAMED
    FDA Enforcement Class II Completed

    PROTEXIS Latex Micro Surgical Gloves Size 8.5 - 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-2918-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2918-2020
    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 8.5 - 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: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139 Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005

    Distribution

    US Nationwide distribution

    Quantity

    7119625 total