Devices

Device Recall ICU STAT 2

  • Model / Serial
    Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • Product Description
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
    ICU Medical, Inc.
  • 1 Event

Manufacturer

ICU Medical, Inc.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall ICU STAT 2
  • Model / Serial
    Lot # 2768416
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • Product Description
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set || w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
    ICU Medical, Inc.
Device Recall ICU STAT 2
  • Model / Serial
    Lot # 2768417
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • Product Description
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set || w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
    ICU Medical, Inc.
Device Recall ICU STAT 2
  • Model / Serial
    Lot # 2801951
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
  • Product Description
    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. || Product Usage: || IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
  • Manufacturer
    ICU Medical, Inc.