BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480

    Recall: Z-1439-2024 · Reported April 10, 2024

    Enforcement

    Recall Number
    Z-1439-2024
    Event ID
    94136
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 10, 2024
    Initiation Date
    February 23, 2024
    Classification Date
    March 29, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480

    Reason

    Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

    Code Info

    a) 66745, UDI/DI 70653160060330 (case) 00653160060331 (each), Lot Numbers: 2023103090; b) 67050, UDI/DI 00653160357509 (case) 10653160357506 (each), Lot Numbers: 2023103090; c) 67430, UDI/DI 10653160123514 (case) 00653160123517 (each), Lot Numbers: 2023022190; d) I67970, UDI/DI 20653160224744 (case) 00653160224740 (each), Lot Numbers: 2023041390, 2023041490, 2023061990, 2023101290; e) I68040, UDI/DI 20653160228605 (case) 00653160228601 (each), Lot Numbers: 2023022190, 2023102090; f) I68340, UDI/DI 00653160279863 (case) 10653160279860 (each), Lot Numbers: 2023042490; g) I68380, UDI/DI 00653160284553 (case) 10653160284550 (each), Lot Numbers: 2023032790, 2023101790; h) I68470, UDI/DI 00653160290721 (case) 10653160290728 (each), Lot Numbers: 2023032190, 2023032390; i) I68480, UDI/DI 00653160292640 (case) 10653160292647 (each), Lot Numbers: 2023013190

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama, Canada.

    Quantity

    20614 units