BEUDAMED
    FDA Recall Terminated

    Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    Recall: Z-0266-2010 · Initiated March 5, 2009

    Recall

    Recall Number
    Z-0266-2010
    Event Number
    53497
    Firm
    Sharn, Inc.
    FEI Number
    3020651884
    Product Code
    CCT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 5, 2009
    Posted
    November 16, 2009
    Terminated
    July 13, 2012
    Address
    4517 George Rd, Ste 200, Tampa, FL, 33634

    Description

    Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    Reason

    Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.

    Action

    Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.

    Distribution

    Nationwide Distribution

    Quantity

    550