Medefil Incorporated

7 devices in the database

  • Model / Serial
    a) catalog # MIH-4422: Lot H210209, exp. date 04/12; Lot H210238, exp. date 05/12; Lot H210265, exp. date 05/12; b) catalog # MIH-4425: Lot H210210, exp. date 04/12; H210241, exp. date 05/12.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • Product Description
    Medefil Heparin I.V. Flush Syringe 1 units/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 units 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 pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe
  • Model / Serial
    a) catalog # MIH-2221: Lot H10228, exp. date 04/12; b) catalog # MIH-2223: Lot H10262, exp. date 05/12; c) catalog # MIH-2235: Lot H10190, exp. date 03/12; Lot H10229, exp. date 04/12; Lot H10278, exp. date 06/12.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • Product Description
    Medefil Heparin I.V. Flush Syringe 10 units/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 10 units 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 pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b) NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c) NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe
  • Model / Serial
    a) catalog # MIH-3333: Lot H109298, exp. date 08/11; Lot H110152, exp. date 01/12; b) catalog # MIH-3335: Lot H109291, exp. date 08/11; Lot H109293, exp. date 08/11; Lot H109295, exp. date 08/11; Lot H109297, exp. date 08/11; H109299, exp. date 08/11; Lot H109300, exp. date 08/11.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • Product Description
    Medefil Heparin I.V. Flush Syringe 100 units/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 100 units 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 pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-333-33, catalog # MIH-3333: 3 mL fill in 12 mL syringe; b) NDC# 64253-333-35, catalog # MIH-3335: 5 mL fill in 12 mL syringe
  • 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
  • Model / Serial
    catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09;  catalog #MIH-2233: lot H08124, exp. date 01/10
  • 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 10 units/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 10 units 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 pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: || a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe || b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe
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