Device Recall Heparin I.V. Flush Syringe, 1 unit/mL

  • Model / Serial
    catalog #MIH-4425: lot H207335, exp. date 11/09
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • Product Description
    Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 || The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • Manufacturer Parent Company (2017)
  • Source
    USFDA