Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26450
  • Event Risk Class
    Class 2
  • Event Number
    Z-0959-03
  • Event Initiated Date
    2003-06-09
  • Event Date Posted
    2003-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27772
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, Administration, Intravascular - Product Code FPA
  • Reason
    The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
  • Action
    The IV administration sets were recalled by letters dated 6/9/03, advising the accounts of the discoloration of the sight chamber and adapters due to the use of non-radiation grade plastic resin in the manufacture of these components of the sets and requesting the return of the sets for credit. These letters were accompanied by a customer ship history/business reply form, which listed the specific set list numbers and lot numbers shipped to the direct account. The direct accounts were requested to send copies of the enclosed recall letter with the listing of all affected sets to their subaccounts. Abbott sent recall letters dated 6/13/03 to those accounts who received I.V. set list 018810458, lot 910824W packed in cases with Liposyn II 20% Kits, list 97920403, lot 92552DF and list 97930403, lot 94553DF. These accounts were informed of the problem with the administration sets and were requested to remove the sets from the Liposyn II cases and return the sets for credit. Abbott sent recall letters dated 7/7/03 to distributors and veterinary clinics receiving the 12 additional lots of primary I.V. sets, list numbers 018810448 and 089620448, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 7/7/03 to the third party manufacturers receiving the affected drip chamber components, informing them of the problem with the drip chambers and requesting the return of the affected lots. Abbott sent recall letters dated 8/19/03 to hospitals and distributors receiving the 9 additional lots of I.V. sets, list numbers 119440402, 119480402, 120300412, 122590402 and 123120401, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 5/13/04 to hospitals and distributor

Device

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
    General Hospital and Personal Use Devices
  • 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
    Abbott Laboratories HPD/ADD

Manufacturer

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