Device Recall Steris

  • Model / Serial
    All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product #s: 157400; 257400; 157500; 257500
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Steriseal-Cannula Ophthalmic; || Bi-Manual Irrigating/Aspirating Handpiece.
  • Manufacturer
  • Model / Serial
    Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
  • Product Description
    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
  • Model / Serial
    All units bearing serial numbers 0432000018 to 0403105051.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
  • Product Description
    Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
  • Product Description
    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
  • Model / Serial
    All Model Numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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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