BEUDAMED
    FDA Recall Open, Classified

    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

    Recall: Z-2107-2025 · Initiated June 24, 2025

    Recall

    Recall Number
    Z-2107-2025
    Event Number
    97136
    Firm
    Preat Corp
    FEI Number
    2918719
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    June 24, 2025
    Posted
    July 10, 2025
    Address
    2625 Skyway Dr, Ste B, Santa Maria, CA, 93455-1405

    Description

    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

    Reason

    Due to manufacturing error, digital analog rotational feature is 180 degrees off.

    Action

    On June 24, 2025 Preat Corporation issued a "Urgent: Medical Device Recall" to affected consignees via certified mail. Preat asked consignees to take following actions: 1. Immediately review your inventory for product listed in the table below. 2. Customers shall stop/cease use of the product in the scope of this recall. 3. It shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 4. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be provided a copy of this notification and informed to notify their customers. 5. Complete and return the Customer Response Form following completion of your reconciliation activities.

    Distribution

    US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.

    Quantity

    44 units