Device Recall Baxter

  • Modèle / numéro de série
    Product Code: 5C4483; All Lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
  • Description du dispositif
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. || intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
  • Source
    USFDA

155 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    product codes 5M5576, 5M5576R, serial numbers 200000 through 202864
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Mexico, China, South Korea, Hong Kong
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Description du dispositif
    0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
  • Modèle / numéro de série
    all lots within expiration date
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Description du dispositif
    100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
  • Modèle / numéro de série
    lots GR182881, GR183558, GR184200, GR185900
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Y-Type Blood/Solution Set, catalog #1C8029; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
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