Device Recall Baxter

  • Model / Serial
    all lots within expiration date of the following pre-filled syringes: Code 2K6049: 3 mL in 12 mL syringe Code 2K6050: 5 mL in 12 mL syringe Code 2K6058: 5 mL in 12 mL syringe w/cannula
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Product Description
    100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA

155 devices with a similar name

Learn more about the data here

  • Model / Serial
    product code 2N5601, lot number UR08C31068
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California and internationally to Japan and Australia
  • Product Description
    Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotating Male Luer Lock; a sterile, nonpyrogenic fluid pathway; product code 2N5601. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
  • Model / Serial
    product code 2C7554s, lot GR293209 *** The recall was expanded to include lots GR291559 and GR294928 ***
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa.
  • Product Description
    Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554s || The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for periods up to 96 hours.
  • Manufacturer
  • Model / Serial
    product code 2N3375, lot number UR09H05029, expiration date 8/25/2014.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including: AL, LA, MO, SD, TX and WV; and country of: Canada.
  • Product Description
    Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 2N3375 || Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
  • Manufacturer
  • Model / Serial
    Product Code 1C8507s, lot numbers GR291542, GR292409, GR292797 and GR294454.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution including the states of Alabama, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, Ohio, Pennsylvania, Tennessee and Virginia.
  • Product Description
    Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. || Baxter Healthcare Corporation. || A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvented and flexible containers.
  • Manufacturer
  • Model / Serial
    product code 2M8064, serial number 8110057FB
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. || The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
  • Manufacturer
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