The Recall Desk

FDA (Devices) recall action 83329

Centurion Medical Products Corporation recalled 13 products on 2019-08-14

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products
13
Announced
2019-08-14
Critical
0
Units
22,066

Why these products were recalled

Potential for sterile packaging to be compromised

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–13 of 13

  • HighFDA (Devices)··2019-08-14

    Centurion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise

    Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.

    Product
    STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.

    Product
    LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Universal Block Tray Recalled for Potential Sterile Packaging Compromise

    Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.

    Product
    UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls Suture Trays Due to Sterile Packaging Concerns

    Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2019-08-14

    Centurion Driveline Management System 1 Daily Kit Recalled for Packaging Risk

    Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.

    Product
    DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.

    Product
    CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
    Category
    Distribution
    19 states
  • SevereFDA (Devices)··2019-08-14

    Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns

    Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.

    Product
    HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.

    Product
    DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Products Recalls Sterile Fluoro SSP Trays Due to Packaging Concerns

    Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.

    Product
    STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration. The kits are used in the diagnostic section of the radiology department, by medical professionals in a clinical setting.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 220 Circumcision Tray kits (Lot # 2019052190) because the sterile packaging may be compromised, posing a risk of infection during newborn procedures.

    Product
    CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk

    Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2019-08-14

    Centurion Neonatal PICC Insertion Tray Recalled for Packaging Compromise

    Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.

    Product
    NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
    Category
    Distribution
    19 states