Device Recall Heparin I.V. Flush Syringe 10 units/mL

  • 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
  • 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 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 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