Device Recall Abbott, Abbott LifeShield & Abbott ColorGard Secondary I.V. Sets

  • Model / Serial
    a) Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch, list 018320468, lots 010015H, 911055H, 921285H, 940565H, 950785H; b) Latex-Free Secondary I.V. Set, Nonvented, 32 Inch, list 018610458, lots 901305H, 910215H, 921465H, 960735H; c) Latex-Free Secondary I.V. Set, Convertible Pin, 35 Inch, list 018890458, lots 920695H, 950175H; d) Latex-Free Secondary I.V. Set with Convertible Pin, 32 Inch, list 019110448, lots 85163HG, 960535H; e) Latex-Free Secondary I.V. Set, Nonvented, 35 Inch, list 019260448, lot 941645H; f) Latex-Free Midlength Secondary I.V. Set, 40 Inch, list 111810401, lots 86029HG, 89100HG; g) LifeShield Latex-Free Secondary I.V. Set, Nonvented, 32 Inch, list 113110448, lots 010324W, 010724W, 910534W, 920934W, 930494W, 950444W, 950714W; h) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch, list 113970458, lots 910624W, 910634W, 911304W, 920674W, 920854W, 920864W, 921214W, 930784W, 931314W, 931324W, 940994W, 941334W, 950574W, 950814W, 950964W, 951054W, 960794W, 960864W; i) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch, list 114850458, lot 911234W; j) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch, list 119530448, lots 010464W, 010474W, 010484W, 010494W, 010504W, 010794W, 010804W, 020634W, 020654W, 020664W, 021034W, 870534W, 870554W, 870874W, 870884W, 871114W, 880674W, 890674W, 900864W, 901044W, 910554W, 910834W, 911244W, 920564W, 920574W, 920944W, 920954W, 921174W, 930504W, 930514W, 930524W, 930714W, 930724W, 930924W, 930934W, 931064W, 931074W, 940554W, 940564W, 940774W, 940784W, 940914W, 940924W, 941104W, 941114W, 941284W, 941294W, 9500464W, 950474W, 950724W, 950924W, 960564W, 960984W, 960994W, 961004W; k) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch, list 119540448, lots 860994W, 861244W; l) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch, list 405210448, lot 911265H; m) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch, list 405220448, lots 890215H, 950135H; n) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch, list 405240448, lots 910075H, 910155H;  o) Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch, list 011390448, lots 010814W, 880514W, 900944W, 901094W, 901264W, 910884W, 920834W, 921084W, 930574W, 930764W, 940644W, 940974W, 950564W, 950804W, 960634W, 960854W, 961134W;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Internationally to Abbott affiliates in Argentina, Aruba, Australia, the Bahamas, Barbados, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Croatia, Curacao, Dominican Republic, Ecuador, Egypt, El Salvador, France, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, Italy, Jordan, Kuwait, Mexico, New Zealand, Nicaragua, Pakistan, Panama, Paraguay, Peru, Suadia Arabia, Singapore, Taiwan, Trinidad, Turkey, United Arab Emirates and Uruguay
  • Product Description
    Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA