Devices

Device Recall Heparin I.V. Flush Syringe 100 units/mL

  • 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
    General Hospital and Personal Use Devices
  • 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
  • Manufacturer
    Medefil Incorporated
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall Heparin I.V. Flush Syringe 100 units/mL
  • Model / Serial
    a) catalog #MIH-3335: lot H107301, exp. date 09/09; H107305, exp. date 09/09; H107309, exp. date 10/09; H107313, exp. date 10/09; H107317, exp. date 10/09; H107322, exp. date 10/09; H107340, exp. date 11/09; H108111, exp. date 12/09; H108116, exp. date 12/09; H108122, exp. date 01/10; H108127, exp. date 01/10;  b) catalog #MIH-3333: lot H107332, exp. date 11/09; H108106, exp. date 12/09; H108118, exp. date 12/09; c) catalog #MIH-3323: lot H108117, exp. date 12/09
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • Product Description
    Medifil 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 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: || a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe || b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe || c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe
  • Manufacturer
    Medefil Incorporated