BEUDAMED
    FDA Enforcement Class II Terminated

    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

    Recall: Z-1468-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1468-2021
    Event ID
    87538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trinity Sterile, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    February 23, 2021
    Classification Date
    April 21, 2021
    Termination Date
    February 16, 2023
    Address
    201 Kiley Dr, N/A, Salisbury, MD, 21801-2249, United States

    Description

    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

    Reason

    Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

    Code Info

    Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001

    Distribution

    US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.

    Quantity

    2970 units