BEUDAMED
    FDA Recall Open, Classified

    Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

    Recall: Z-0235-2024 · Initiated August 31, 2023

    Recall

    Recall Number
    Z-0235-2024
    Event Number
    93179
    Firm
    Pulmonx, Corp.
    FEI Number
    3007797756
    Product Code
    NJK
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    August 31, 2023
    Posted
    November 6, 2023
    Address
    700 Chesapeake Dr, Redwood City, CA, 94063-4731

    Description

    Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

    Reason

    Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.

    Action

    On 8/31/23, correction notices were emailed to customers who were asked to do the following: 1) The affected lot can be used without risk to the patient until 08 December 2024. In addition, this lot was manufactured on 2021-12-08. 2) Check your inventory and keep this letter with any remaining product of the affected lot to support the corrected manufacture and expiration date. 3) Send a response email acknowledging receipt that includes the number of affected devices remaining at your site. Customers with questions can call 650-743-6848.

    Distribution

    US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI

    Quantity

    144