BEUDAMED
    FDA Enforcement Class II Ongoing

    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT12060; e) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT14705; f) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17190; g) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17195; h) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT17755; i) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT18475; j) CENTURION MEDICAL PRODUCTS SUTURE SET, Reorder Number SUT19505; k) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT19620; l) CENTURION MEDICAL PRODUCTS UNITYPOINT HEALTH LACERATION T, Reorder Number SUT20205; m) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT20410; n) CENTURION MEDICAL PRODUCTS BASIC SUTURE TRAY, Reorder Number SUT21360; o) CENTURION MEDICAL PRODUCTS SUTURE PACK TRAY, Reorder Number SUT4655; p) CENTURION MEDICAL PRODUCTS SUTURING SET, Reorder Number SUT5765; q) CENTURION MEDICAL PRODUCTS UMBILICAL CATH INSERT TRAY, NO, Reorder Number UVT1075A; r) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL CATH INSERT T, Reorder Number UVT505; s) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL TRAY, Reorder Number UVT835;

    Recall: Z-1119-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1119-2023
    Event ID
    91483
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    February 10, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT12060; e) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT14705; f) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17190; g) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT17195; h) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT17755; i) CENTURION MEDICAL PRODUCTS LACERATION TRAY (P/S), Reorder Number SUT18475; j) CENTURION MEDICAL PRODUCTS SUTURE SET, Reorder Number SUT19505; k) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT19620; l) CENTURION MEDICAL PRODUCTS UNITYPOINT HEALTH LACERATION T, Reorder Number SUT20205; m) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT20410; n) CENTURION MEDICAL PRODUCTS BASIC SUTURE TRAY, Reorder Number SUT21360; o) CENTURION MEDICAL PRODUCTS SUTURE PACK TRAY, Reorder Number SUT4655; p) CENTURION MEDICAL PRODUCTS SUTURING SET, Reorder Number SUT5765; q) CENTURION MEDICAL PRODUCTS UMBILICAL CATH INSERT TRAY, NO, Reorder Number UVT1075A; r) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL CATH INSERT T, Reorder Number UVT505; s) CENTURION MEDICAL PRODUCTS UMBILICAL VESSEL TRAY, Reorder Number UVT835;

    Reason

    The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

    Code Info

    a) Reorder Number CVI2105, GTIN 40653160091546, Lot #22HMD248; b) Reorder Number MNS11975, GTIN 40653160325292, Lot #22HMD116; c) Reorder Number SUT11670, GTIN 40653160109762, Lot #22HMB913; d) Reorder Number SUT12060, GTIN 40653160120279, Lot #22HMC040; e) Reorder Number SUT14705, GTIN 40653160185438, Lot #22HMF267, 22HMF925; f) Reorder Number SUT17190, GTIN 40653160229231, Lot #22HMC041; g) Reorder Number SUT17195, GTIN 40653160229705, Lot #22HMH826; h) Reorder Number SUT17755, GTIN 40653160243701, Lot #22HMG491; i) Reorder Number SUT18475, GTIN 40653160258958, Lot #22HMH512; j) Reorder Number SUT19505, GTIN 40653160286166, Lot #22HMI064; k) Reorder Number SUT19620, GTIN 40653160289266, Lot #22HME946; l) Reorder Number SUT20205, GTIN 40653160293065, Lot #22IMA294; m) Reorder Number SUT20410, GTIN 40653160307052, Lot #22HME368; n) Reorder Number SUT21360, GTIN 40653160329436, Lot #22IMA124; o) Reorder Number SUT4655, GTIN 40653160015582, Lot #22HMC982; p) Reorder Number SUT5765, GTIN 40653160015865, Lot #22HMF927; q) Reorder Number UVT1075A, GTIN 10653160341956, Lot #22BBJ015; r) Reorder Number UVT505, GTIN 40653160182055, Lot #22FMF860; s) Reorder Number UVT835, GTIN 40653160289181, Lot #22GMF784

    Distribution

    Nationwide

    Quantity

    2753 units