BEUDAMED
    FDA Recall Terminated

    10 ga ARS Decompression Needle, Part Number ZZ-0298

    Recall: Z-2520-2021 · Initiated August 27, 2021

    Recall

    Recall Number
    Z-2520-2021
    Event Number
    88603
    Firm
    North American Rescue LLC.
    FEI Number
    3005034064
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 27, 2021
    Terminated
    January 19, 2024
    Address
    35 Tedwall Ct, Greer, SC, 29650-4791

    Description

    10 ga ARS Decompression Needle, Part Number ZZ-0298

    Reason

    The device includes the incorrect Instructions for Use.

    Action

    Consignees will be notified by 09/01/2021 via email with read/delivery receipt followed by First Class Mail letter. Additionally, the recall notification will be posted to the firm's website, www.marescue.com. Consignees are asked to do the following: 1. Examine your inventory and quarantine all product identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in this recall notification. 3. Identify the ZZ-0298, with the aid of ENCLOSURE 1, and verify the recalled lot W668NI, W693WF, W694ZH, W695DD, W696FN, or W697IJ. UDI number 00842209108831. 4. Complete the Recall Return Response Form in ENCLOSURE 2, including all requested information, even if you do not have the recalled product. 5. Contact [email protected] and provide your completed Recall Return Response Form in order to receive a replacement and arrange for the return of the recalled lots. 6. For assistance completing these steps or questions regarding your order, please contact NAR Customer Service toll free at 1-888-689-6277. (Please have your customer order number available to reference.) This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent patient harm. If you have further distributed this product, please: 1. Identify your customers and immediately notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please complete and return the Recall Return Response Form, in ENCLOSURE 2, as soon as possible. If you have any questions, call William Slevin at (864) 675-9800.

    Distribution

    Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland

    Quantity

    51,424 units