Class 2 Device Recall Abbott, Abbott LifeShield & Abbott ColorGard Secondary I.V. Sets

• Date Initiated by Firm: June 09, 2003
• Date Posted: June 27, 2003
• Recall Status: Terminated on August 27, 2004
• Recall Number: Z-0959-03
• Recall Event ID: 26450
• 510(K)Number: K912103 K832755
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD; 100/200 Abbott Park Road; Abbott Park IL 60064
• For Additional Information Contact: Abbott Customer Service; 800-222-6883
• Manufacturer Reason for Recall: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
• FDA Determined Cause: Other
• 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
• Quantity in Commerce: 10,077.349 sets
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = ABBOTT LABORATORIES; 510(K)s with Product Code = FPA and Original Applicant = OMNI-GLOW, INC.