BEUDAMED
    FDA Recall Terminated

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    Recall: Z-2749-2018 · Initiated June 4, 2018

    Recall

    Recall Number
    Z-2749-2018
    Event Number
    80584
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    IFB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 4, 2018
    Terminated
    June 7, 2019
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    Description

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    Reason

    Mislabeled product

    Action

    On June 4, 2018, ThermoFisher Scientific issued URGENT MEDICAL DEVICE RECALL notices to customers. Customers were advised to inspect stock, quarantine, safely dispose or return impacted product. Evidence of disposal is required to be sent to Thermo Shandon Limited. If affected product has been used with no issues, please notify Thermo Shandon Limited of the quantity that is unavailable for disposal. Complete and return the Recall Return Response Acknowledgement & Receipt form via email to [email protected]

    Distribution

    US Nationwide Distribution

    Quantity

    1,039 cases/40 boxes per case