BEUDAMED
    FDA Recall Open, Classified

    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

    Recall: Z-1735-2025 · Initiated March 27, 2025

    Recall

    Recall Number
    Z-1735-2025
    Event Number
    96622
    Firm
    Galt Medical Corporation
    FEI Number
    3000718472
    Product Code
    OFL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 27, 2025
    Posted
    May 7, 2025
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137

    Description

    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

    Reason

    Due to a potential open seal in the sterile barrier packaging.

    Action

    On 03/27/2025, the firm emailed customers an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that affected products may have an open seal in the sterile barrier packaging that will render the product non-sterile and will increase the risk of patient harm due to microbial and environmental contamination. Customers are instructed to: 1.DO NOT USE OR DISTRIBUTE THE DEVICEs LISTED IN THIS RECALL. Identify and segregate the affected lot(s) that are in their possession as well as those in the possession of their end-users. 2. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of the Corrections Coordinator at [email protected] or 214-778-1433. We have enclosed two forms: one to account for inventory at their facility and the other for capturing these exact details from their end users. The form lists the product number, lot number, and quantity that the firm's records indicate their facility has received. It is essential that, even if they do not have any product remaining in their possession, they complete the attached forms (Attachment A & B), indicating zero quantity to be returned, and email or fax the forms to GALT MEDICAL CORP. 3. Ship the returned product to GALT MEDICAL CORP. using Galt s carrier account information listed on the forms. 4. Reference Return Authorization Number RMA# 1200 on the outside of the shipping box and include a copy of the Field Correction Reply Forms with their shipment. 5. Once the completed Field Correction Reply Forms have been received and processed, Galt will issue a credit to customers for the returned product. Please place a new purchase order (PO), noting Replacement Parts for new products. For questions, contact Quality Director at 1-214-778-1306

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

    Quantity

    4,280 kits