BEUDAMED
    FDA Recall 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 · Initiated June 6, 2016

    Recall

    Recall Number
    Z-2122-2016
    Event Number
    74300
    Firm
    Covidien, LLC
    FEI Number
    3004904811
    Product Code
    EOX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 6, 2016
    Terminated
    October 18, 2017
    Address
    540 Oakmead Pkwy, Sunnyvale, CA, 94085-4022

    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.

    Action

    The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance [email protected] or fax to (203) 492-7719 if Product purchased through distributor or you have "no inventory"; and to promptly alert any other person or facilities if they have further distributed the product. All affected lots must be returned. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.

    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)