BEUDAMED
    FDA Enforcement Class II Terminated

    Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

    Recall: Z-0898-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0898-2022
    Event ID
    89795
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 4, 2022
    Classification Date
    April 8, 2022
    Termination Date
    March 20, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

    Reason

    Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

    Code Info

    Lot #3139133, Exp. 11/01/2022.

    Distribution

    US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.

    Quantity

    7,800 pouched syringes