BEUDAMED
    FDA Recall Open, Classified

    SQ40S Blood Transfusion Filter

    Recall: Z-1157-2026 · Initiated November 3, 2025

    Recall

    Recall Number
    Z-1157-2026
    Event Number
    98145
    Firm
    GVS TM, Inc
    FEI Number
    2013342
    Product Code
    CAK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 3, 2025
    Posted
    January 22, 2026
    Address
    1630 W Industrial Park St, Covina, CA, 91722-3419

    Description

    SQ40S Blood Transfusion Filter

    Reason

    Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

    Action

    On 11/03/2025, the firm sent via email a "GVS TM Inc Customer Statement" informing customers that GVS TM Inc discovered that some of the products in the affected lot may have been damaged during the transportation process. To avoid any potential risk this damage may pose to the downstream user, the firm is requesting return of the affected products. On 11/18/2025, the firm sent via email a "GVS TM Inc Product Recall Statements" informing customers that the products were distributed before completion of the required quality control release process, including final review of sterilization documentation and Certificate of Analysis. As a result the sterility assurance cannot be confirmed. Customers are instructed to: 1) Return all units of Lot 7536142 to GVS TM Inc - Customer Service using GVS TM FedEx Account 203742698, or 2) Destroy the affected units at their facility according to their internal disposal procedures for medical devices. 3) Confirmation Required - If Returning Product --Quantity returned --Date Shipped Back --Contact Person - If Destroying Product (Proof of Destruction Required) --Signed destruction confirmation --Statement on facility letterhead indicating: ---Quantity destroyed ---Date of Destruction ---Method of disposal ---Name/title of the person performing destruction Upon receipt of the above information, GVS TM Inc will issue replacements or credit depending on customer's preference. Questions - Contact GVS TM Customer Service at customerservice [email protected]

    Distribution

    U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA

    Quantity

    2,720 filters