Device Recall 90" Y Tubing with single check valve

  • Model / Serial
    Catalog #: 801107; Lot #: 0029498, 0032077, 0057617, 0057618, 0064350, 0081113, 0095185, 0109043, 0123064, 0130215, 0148235, 0162122, 0169315, 0197173, 0225223, 0253258, 0260252, 0273018, 0273019, 0278107, 0279093, 0288031, 0288032, 0295180, 0295181, 0307122, 0307123, 0330175, 0330176, 0330177, 0337127, 0337128, 0351231, 0351232, 0355139, 0355140, 1014140, 1014141, 1021230, 1028227, 1042218, 1042219, 1056019, 1056020, 1063217, 1063218, 1070126, 1084124, 1091205, 1098204, 1098205, 1105212, 1105213, 1112018, 1112019, 1119053, 1126122, 1126123, 1133132, 1133133, 1154165, 1154166, 1161159, 1168128, 1175136, 1182146, 1182147, 1196144, 1196145, 1196146, 1203191, 1203192, 1210164, 1210165, 1238131, 1238132, 1252125, 1252126, 1287132, 1287133, 1343174, 1343175, 9022000, 9037137, 9044169, 9044186, 9058254, 9058255, 9072268, 9072269, 9086222, 9100259, 9100260, 9107248, 9107249, 9114148, 9114149, 9135202, 9135203, 9149184, 9149185, 9163185, 9163186, 9170276, 9170277, 9187008, 9191018, 9191019, 9212121, 9212122, 9233028, 9233029, 9260011, 9260012, 9275100, 9281042, 9295023, 9317046, 9320079, 9327016, 9334064, 9345196, 9345661.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Mallinckrodt Optistar Elite 90" 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

Manufacturer

  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA