Devices

Device Recall HEPARIN LOCK FLUSH SOLUTION

  • Modèle / numéro de série
    Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Description du dispositif
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only || To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
  • Manufacturer
    App Pharmaceuticals Llc
  • 1 Event

Fabricant

App Pharmaceuticals Llc
  • Adresse du fabricant
    App Pharmaceuticals Llc, 1501 E Woodfield Rd, Suite 300 East, Schaumburg IL 60173-6052
  • Société-mère du fabricant (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA

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Device Recall HEPARIN LOCK FLUSH SOLUTION
  • Modèle / numéro de série
    Lot 406952 (Expiration Date 02/11)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Description du dispositif
    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only || To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
  • Manufacturer
    App Pharmaceuticals Llc