Device Recall 60" Y Tubing with single check valve

  • Modèle / numéro de série
    Catalog #: 801106; Lot #s: 0004089, 0022187, 0029497, 0057616, 0064349, 0067042, 0074025, 0081112, 0088168, 0095184, 0102056, 0109042, 0120266, 0127204, 0134340, 0141206, 0169314, 0204181, 0246195, 0253136, 0267019, 0288027, 0295179, 0302179, 0316141, 0323177, 0323178, 0337126, 0344213, 0344214, 0351233, 0351234, 1007196, 1007197, 1021229, 1028226, 1035284, 1049308, 1049309, 1154164, 1175177, 1217150, 1224136, 1231122, 1238129, 1238130, 1266168, 9058264, 9065162, 9100338, 9107246, 9107247, 9121111, 9135200, 9135201, 9149180, 9149181, 9163184, 9191016, 9191017, 9205006, 9205007, 9240130, 9247097, 9260010, 9275099, 9281041, 9295022, 9317527, 9338341, 9345195, 9345660
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and Uruguay.
  • Description du dispositif
    Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. || Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA