Device Recall Baxter

  • Model / Serial
    catalog 2C7623, lot numbers UR124917 through UR158857. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
  • Product Description
    Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • 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
    All serial numbers manufactured from 11/1/2005 to 4/22/2013, with release dates 1/1/2005 and forward.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB || Product Usage: || The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
  • Manufacturer
  • Model / Serial
    All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 || Product Usage: || The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
  • Manufacturer
  • Model / Serial
    product codes 5M5576, 5M5576R, serial numbers 200000 through 202864
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Mexico, China, South Korea, Hong Kong
  • Product Description
    Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 || The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
  • Manufacturer
  • Model / Serial
    all lots within expiration date of the following pre-filled syringes: Code 2K0901: 2 mL in 3 mL syringe Code 2K0903: 3 mL in 6 mL syringe Code K0905: 5 mL in 12 mL syringe Code 2K0906: 10 mL in 12 mL syringe Code 2K6011: 2 mL in 3 mL syringe w/cannula Code 2K6012: 3 mL in 6 mL syringe w/ cannula Code 2K6013: 5 mL in 12 mL syringe w/cannula Code 2K6014: 10 mL in 12 mL syringe w/cannula
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Product Description
    0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
  • Model / Serial
    all lots within expiration date
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Product Description
    10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
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