Device Recall LAPAROTOMY PACK

  • 모델명 / 제조번호(시리얼번호)
    Code: 900996 Lots: 141015747 exp. 11/30/15 150116833 exp. 2/28/16 150317665 exp. 3/31/16 150318129 exp. 3/31/16 150518851 exp. 5/31/16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    LAPAROTOMY PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 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)
    Code:900176 Lots: 141216310 exp. 12/31/15 150116977 exp. 1/31/16 150116977 exp. 1/31/16 150116775 exp. 1/31/16 150116772 exp. 1/31/16 150116774 exp. 1/31/16 150116773 exp. 1/31/16 150317694 exp. 3/31/16 150317695 exp. 3/31/16 150317696 exp. 3/31/16 150317697 exp. 3/31/16 150317698 exp. 3/31/16 150317693 exp. 3/31/16 150418316 exp. 4/30/16 150418317 exp. 4/30/16 150418578 exp. 4/30/16 150418579 exp. 4/30/16 150519009 exp. 5/31/16 150619364 exp. 6/30/16 150619365 exp. 6/30/16 150619366 exp. 6/30/16 150619367 exp. 6/30/16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    LAPAROTOMY PACK CUSTOMED 7/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Code:9002516 Lots: 140915508 exp. 11/30/15 140915508 exp. 11/30/15 141216306 exp. 12/31/15 150116544 exp. 1/31/16 150116544 exp. 1/31/16 150418376 exp. 4/30/16 150317845 exp. 4/30/16 150418377 exp. 5/31/16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    LAPAROTOMY PACK 4/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Code:900848 Lots: 140915201 exp. 1/31/16 140915249 exp. 11/30/15 150318126 exp. 4/30/16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Only in Puerto Rico.
  • 제품 설명
    LAPAROTOMY PACK CS/6 || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to Louisiana and Montana.
  • 제품 설명
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. || There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot 55689, 55263, and 57680
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to Louisiana and Montana.
  • 제품 설명
    Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. || There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
  • Manufacturer
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