BEUDAMED
    FDA Recall Terminated

    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

    Recall: Z-2051-2021 · Initiated June 15, 2021

    Recall

    Recall Number
    Z-2051-2021
    Event Number
    88074
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 15, 2021
    Terminated
    January 12, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

    Reason

    There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

    Action

    On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to [email protected], even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.

    Distribution

    United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.

    Quantity

    4,752 units