Device Recall Baxter

  • Model / Serial
    catalog 2C9901, lot numbers U563262R through UR102517. 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 Solution Set, 10 drops/mL, 76'', Luer Activated Valve, Male Luer Lock Adapter, catalog 2C9901; 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 Lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
  • Product Description
    Baxter, RAPIDFILL Syringe Strip, 10 ml. || For use with RAPIDFILL Automated Syringe Filler (ASF)
  • Manufacturer
  • Model / Serial
    Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
  • Product Description
    Actifuse ABX/Actifuse MIS System || A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
  • Manufacturer
  • Model / Serial
    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natiowide, Puerto Rico and Canada
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
  • Manufacturer
  • 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
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