BEUDAMED
    FDA Recall Open, Classified

    Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

    Recall: Z-1758-2025 · Initiated April 17, 2025

    Recall

    Recall Number
    Z-1758-2025
    Event Number
    96645
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    KNT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 17, 2025
    Posted
    May 20, 2025
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

    Reason

    Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

    Action

    On April 17, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Correction" Notification to affected consignees. BD asked consignees to take the following actions: 1. Follow the above plastic plug removal instructions. 2. Post this notice where the devices are stored. 3. Please check all inventory locations within your institution for affected products 4. Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred 5.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of this notification 6.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)

    Distribution

    US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom