BEUDAMED
    FDA Enforcement Class II Terminated

    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.

    Recall: Z-0506-2020 · Reported November 27, 2019

    Enforcement

    Recall Number
    Z-0506-2020
    Event ID
    83921
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2019
    Initiation Date
    September 17, 2019
    Classification Date
    November 21, 2019
    Termination Date
    May 21, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.

    Reason

    Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.

    Code Info

    Lot 9850522

    Distribution

    US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.

    Quantity

    41 units