Device Recall Steris

  • 모델명 / 제조번호(시리얼번호)
    All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
  • 제품 설명
    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

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  • 모델명 / 제조번호(시리얼번호)
    Product #s: 157400; 257400; 157500; 257500
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
  • 제품 설명
    Steriseal-Cannula Ophthalmic; || Bi-Manual Irrigating/Aspirating Handpiece.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
  • 제품 설명
    C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All units bearing serial numbers 0432000018 to 0403105051.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
  • 제품 설명
    Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    The following serial/lot numbers are affected by this recall:  0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
  • 제품 설명
    STERIS Fine Traction Device, one unit per box || Product Usage: || The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Model Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.
  • 제품 설명
    The STERIS 4085 General Surgical Table || Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
  • Manufacturer
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