BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702

    Recall: Z-3053-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3053-2024
    Event ID
    94583
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 18, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    September 6, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Code Info

    613034700, Lot Number 20ADD340 ; 613034700, Lot Number 20BDC393 ; 613034700, Lot Number 20BDC472 ; 613034700, Lot Number 20BDC473 ; 613034700, Lot Number 20FDA390 ; 613034700, Lot Number 20FDA896 ; 613034700, Lot Number 20FDA897 ; 613034700, Lot Number 20FDA898 ; 613034700, Lot Number 20FDA896A; 613034700, Lot Number 20JDB120 ; 613034700, Lot Number 21CDA660 ; 613034700, Lot Number 21DDB193 ; 613034700, Lot Number 21IDA396 ; 613034700, Lot Number 21LDB900 ; 613034700, Lot Number 22ADB549 ; 613034701, Lot Number 21CDA617 ; 613034701, Lot Number 21DDB192 ; 613034701, Lot Number 21IDB791 ; 613034701, Lot Number 21JDB094 ; 613034701, Lot Number 22BDB700 ; 613034702, Lot Number 21CDA618 ; 613034702, Lot Number 21DDB222 ; 613034702, Lot Number 21IDB804 ; 613034702, Lot Number 21LDB713

    Distribution

    Worldwide distribution.