BEUDAMED
    FDA Enforcement Class II Terminated

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    Recall: Z-0199-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0199-2023
    Event ID
    90981
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Access Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2022
    Initiation Date
    February 24, 2021
    Classification Date
    November 7, 2022
    Termination Date
    May 30, 2024
    Address
    749 Middlesex Tpke, N/A, Billerica, MA, 01821-3906, United States

    Description

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    Reason

    Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

    Code Info

    UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021

    Distribution

    Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

    Quantity

    79 kits