Device Recall 60 mL Syringe w/Lateral Flow Needle

  • Model / Serial
    Catalog #: 801801; Lot #: 0008414, 0008415, 0015042, 0015043, 0022236, 0029499, 0029500, 0036252, 0036253, 0060075, 0064356, 0067043, 0071245, 0074027, 0078240, 0081116, 0085386, 0088170, 0095186, 0099109, 0102058, 0106079, 0109044, 0113426, 0120272, 0120472, 0123066, 0134341, 0141207, 0155153, 0155154, 0162123, 0235010, 0235011, 0246196, 0246197, 0260208, 0260209, 0300141, 0300142, 0309197, 0309198, 0316143, 0316144, 0316145, 0323181, 0337129, 0337130, 1007198, 1007199, 1007200, 1007201, 1021246, 1028228, 1028229, 1028230, 1028231, 1028232, 1035285, 1035286, 1035287, 1035288, 1042122, 1042123, 1049310, 1049311, 1049312, 1049313, 1056021, 1056022, 1063219, 1063220, 1070128, 1070129, 1084125, 1084126, 1091216, 1091217, 1098211, 1098212, 1105219, 1105220, 1119061, 1119062, 1119063, 1119064, 1147187, 1147188, 1154167, 1154168, 1217151, 1224177, 1231123, 1231124, 1238134, 1252133, 1252134, 1266175, 1266176, 1273129, 1273130, 1280130, 1280131, 1287134, 1287135, 1294121, 1294122, 1301131, 1301132, 1308138, 1315138, 1315139, 1322137, 1336335, 1336336, 1343177, 9023166, 9037138, 9037139, 9044170, 9044184, 9051152, 9051153, 9058256, 9058257, 9065164, 9065165, 9065448, 9072267, 9079179, 9079180, 9093273, 9093274, 9100261, 9100262, 9114150, 9114151, 9128089, 9128090, 9156194, 9156195, 9163187, 9163188, 9176144, 9176145, 9191020, 9191021, 9219142, 9219143, 9240131, 9240132, 9247098, 9247099, 9253017, 9253018, 9275101, 9275102, 9281033, 9281034, 9295029, 9295030, 9310048, 9310049, 9317055, 9317056, 9331148, 9331149, 9334065, 9338345, 9351119, 9352231, 9357639
  • 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 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 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