BEUDAMED
    FDA Enforcement Class III Ongoing

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;

    Recall: Z-2036-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-2036-2024
    Event ID
    94518
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 19, 2024
    Initiation Date
    March 4, 2024
    Classification Date
    June 7, 2024
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;

    Reason

    The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

    Code Info

    a. UDIDI 00350770002958, all lot numbers, SAP Numbers 120000508, 120001160; b. UDIDI 00350770002996, all lot numbers, SAP Numbers 120000512, 120001164; c. UDIDI 00350770002965, all lot numbers, SAP Numbers 120000509, 120001161; d. UDIDI 00350770003009, all lot numbers, SAP Numbers 120000513, 120001165; e. UDIDI 00350770003016, all lot numbers, SAP Numbers 120000514, 120001166; f. UDIDI 00350770002972, all lot numbers, SAP Numbers 120000510, 120001162; g. UDIDI 00350770003023, all lot numbers, SAP Numbers120000515, 120001167; h. UDIDI 00350770002989, all lot numbers SAP Numbers 120000511, 120001163

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

    Quantity

    27,664 cases (12,155,300 units)