BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

    Recall: Z-2122-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2122-2016
    Event ID
    74300
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    June 6, 2016
    Classification Date
    July 5, 2016
    Termination Date
    October 18, 2017
    Address
    540 Oakmead Pkwy, N/A, Sunnyvale, CA, 94085-4022, United States

    Description

    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

    Reason

    Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.

    Code Info

    Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015

    Distribution

    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

    Quantity

    620 total units (260 US; 360 OUS)