Device Recall Heparin I.V. Flush Syringe

  • 모델명 / 제조번호(시리얼번호)
    Product Number: MIH-3333;  NDC Number: 64253-333-33;  Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.
  • 제품 설명
    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09;  catalog #MIH-2233: lot H08124, exp. date 01/10
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • 제품 설명
    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
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    catalog #MIH-4425: lot H207335, exp. date 11/09
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • 제품 설명
    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
  • Manufacturer
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