BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Custom Packs to be used in surgical procedures.

    Recall: Z-2171-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2171-2020
    Event ID
    85502
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Contract Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 10, 2020
    Initiation Date
    April 13, 2020
    Classification Date
    May 29, 2020
    Termination Date
    November 25, 2020
    Address
    Jackson Pointe Commerce, 4050 Jacksons Pointe Ct, Zelienople, PA, 16063-2838, United States

    Description

    Sterile Custom Packs to be used in surgical procedures.

    Reason

    The surgical gowns were manufactured in a facility that is not registered by the FDA.

    Code Info

    ACS Tray Numbers: AGLH66F; Lot # 674191, Exp. Date [date] (244 kits) AGAD45I; Lot# 681191, Exp. Date 11/15/2020 (35 kits)

    Distribution

    US Nationwide distribution including in the state of Pennsylvania.

    Quantity

    2868 total kits