BEUDAMED
    FDA Recall Open, Classified

    Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

    Recall: Z-1407-2023 · Initiated March 2, 2023

    Recall

    Recall Number
    Z-1407-2023
    Event Number
    91894
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    HFX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 2, 2023
    Posted
    April 19, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

    Reason

    The CirClamp subassembly found in the kit was the incorrect size.

    Action

    The recalling firm issued letters dated 3/2/2023 via first class mail informing the consignee of the issue and to remove it from stock and dispose of it. The letter provided required actions which again included destroying the affected product and to return the completed enclosed destruction form listing the quantity of affected product destroyed. Once the destruction form is received, the account will be issued a credit. If the device has been transferred to another individual, department or location, the consignee is to notify them of this recall communication.

    Distribution

    US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.

    Quantity

    162 units