BEUDAMED
    FDA Recall Open, Classified

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    Recall: Z-1937-2025 · Initiated May 2, 2025

    Recall

    Recall Number
    Z-1937-2025
    Event Number
    96807
    Firm
    Copan Italia Via Francesco Perotti 10
    FEI Number
    3002444944
    Product Code
    JTW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 2, 2025
    Posted
    June 9, 2025
    Address
    18 Brescia Italy

    Description

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    Reason

    Swabs for specimen collection may be prone to breakage during product usage.

    Action

    On May 2, 2025, Copan Italia Spa issued a Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Copan asked consignees to take the following steps: 1. Trace and dispose of all affected products 2. Disposal must be carried out according to local regulations. Evidence or declaration of Product disposal must be returned in writing 3. This notice should be passed on to all those who need to be aware within your organization. if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter and submit the acknowledgment form.

    Distribution

    US Nationwide distribution in the state of MD.

    Quantity

    81,600 units