Class 2 Device Recall Abbott, Abbott LifeShield & Abbott Continuum LifeShield Primary IV Sets

• Date Initiated by Firm: June 09, 2003
• Date Posted: June 27, 2003
• Recall Status: Terminated on August 27, 2004
• Recall Number: Z-0957-03
• Recall Event ID: 26450
• 510(K)Number: K971293 K920736 K833741 K770518 K832755
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 95 different sets listed in the code information section below. Please note, item k, list 018810458, lot 910824W, was also case packed with Liposyn II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02, lot 92522DF, distributed by Abbott Laboratories, North Chicago, IL 60064
• Code Information: a) Latex-Free Primary I.V. Set, Nonvented, 100 Inch, list 017280458, lots 920844W, 960784W; b) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 018180448, lots 910604W, 960604W; c) Latex-Free Primary I.V. Set, Nonvented, 100 Inch, list 018190448, lot 020844W; d) Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch, list 018200478, lots 880884W, 891554W, 910614W, 920824W, 931134W, 960614W; e) Primary I.V. Set, Nonvented, 72 Inch, list 018570448, lots 010524W, 900634W, 940624W; f) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 018590448, lots 891184W, 900844W, 920784W, 930444W, 930884W, 931214W, 941274W, 950684W, 960504W; g) Primary I.V. Set, Nonvented, 78 Inch, list 018600448, lot 920654W; h) Latex-Free Primary I.V. Set, Nonvented, 80 Inch, list 018770468, lots 901224W, 941124W, 950484W; i) Latex-Free Y-Type Primary I.V. Set, Nonvented, 86 Inch, list 018790458, lot 960725H; j) Latex-Free Primary I.V. Set, Vented, 78 Inch, list 018810448, lots 860504W, 880454W, 890624W, 920904W **** expanded to include lots 010304W, 930454W, 930464W and 960514W ****; k) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch, list 018810458, lots 890914W, 910824W, 911004W, 921134W, 930704W, 931234W, 931244W, 940544W, 950434W, 950694W, 951104W, 960524W, 960534W; l) Latex-Free Primary I.V. Set, 78 Inch, list 030840448, lot 960544W; m) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 049670478, lots 020884W, 901274W, 921004W, 940834W; n) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 049680478, lots 910894W, 921204W; o) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 049850478, lots 020524W, 910844W, 931254W, 950624W; p) Latex-Free Cardiac Catheterization Set, Nonvented, 67 Inch, list 064140458, lot 931505H; q) Latex-Free Manifold III with Secure Lock, list 064620401, lot 89114HG; r) Latex-Free Primary I.V. Set, Nonvented, 106 Inch, list 080820448, lots 900874W, 901244W, 920974W, 930544W, 950634W, 950934W, 961044W; s) Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch, list 080830478, lots 880834W; 931294W; t) Primary I.V. Set, Vented, 72 Inch, list 089620448, lots 870514W, 880504W, 890934W, 891654W, 900524W, 901184W, 920554W **** expanded to include lots 020494, 930484W, 930904W, 931304W, 941094W, 950704W, 960964W and 960974W ****; u) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 113060458, lots 920984W, 931094W; v) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch, list 113080458, lots 920075H, 930455H, 940075H; w) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch, list 113090458, lots 871174W, 881054W, 901254W, 910854W, 920994W, 930554W, 930964W, 940584W, 940944W, 941304W, 950514W, 950524W, 950744W, 960584W; x) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 114110478, lots 910654W, 950584W; y) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch, list 115390478, lots 880985H, 911035H, 931305H; z) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 115400458, lots 870974W, 900934W, 911284W, 921184W, 940634W, 950664W, 960764W, 961104W, 961114W; aa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch, list 115410458, lot 920115H; bb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 115420458, lot 921194W; cc) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch, list 115450458, lots 900964W, 910914W, 921224W, 931144W, 951124W; dd) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 115500478, lots 891354W, 951064W; ee) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 115530458, lots 021235H, 911285H, 940325H; ff) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 116780478, lot 87123HG; gg) LifeShield Latex-Free Primary I.V. Set, Nonvented, 100 Inch, list 116790448, lot 930075H; hh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 117190478, lot 881334W; ii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 117350478, lot 881395H; jj) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 117360478, lot 900385H; kk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch, list 117390478, lots 900355H, 940395H; ll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 117620478, lot 901435H mm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 119600468, lots 010544W, 020704W, 871204W, 900974W, 901104W, 901304W, 910664W, 910924W, 920684W, 920874W, 930594W, 930804W, 931154W, 940844W, 941004W, 941174W, 950594W, 950604W, 950824W, 960644W, 960874W; nn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 119610468, lots 010554W, 010564W, 010574W, 010584W, 010594W, 020714W, 870754W, 870764W, 870774W, 871034W, 880724W, 880744W, 880964W, 880994W, 890814W, 890824W, 901114W, 910674W, 910684W, 911334W, 920694W, 921014W, 921024W, 921264W, 921274W, 921284W, 921294W, 921304W, 930604W, 930614W, 930624W, 930634W, 930814W, 931004W, 931014W, 931164W, 940654W, 940664W, 940674W, 940854W, 940864W, 941014W, 941024W, 941034W, 941184W, 941194W, 941354W, 941364W, 950834W, 950844W, 950974W, 950984W, 951074W, 951084W, 951094W, 960884W, 961154W, 961164W, 961174W, 961184W; oo) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 119620478, lots 891334W, 900584W, 901214W, 910574W, 911034W, 911254W, 920794W, 951114W; pp) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 119630468, lots 020965H, 910035H, 910135H, 920015H, 930095H, 940085H, 960155H; qq) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 119650468, lots 010404W, 010414W, 010424W, 020554W, 020564W, 020984W, 020994W, 021194W, 021204W, 870924W, 870934W, 870944W, 880474W, 911264W, 920474W, 920814W, 921074W, 930744W, 930754W, 930974W, 930984W, 931104W, 931414W, 931424W, 931434W, 940814W, 940824W, 940954W, 941154W, 941314W, 950534W, 950544W, 950754W, 960594W960744W, 960754W, 960834W, 961054W, 961064W, 961074W; rr) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch, list 119970448, lot 950155H; ss) Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch, list 120580478, lot 911235H; tt) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch, list 120590448, lots 020545H, 890185H; uu) Latex-Free Fat Emulsion I.V. Set, Convertible Pin, 110 Inch, list 120600458, lot 911515H; vv) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 124260448, lot 921435H; ww) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 124520448, lot 880685H; xx) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 124530448, lots 020045H, 920295H; yy) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 110 Inch, list 125720448, lot 88161HG; zz) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch, list 125740448, lot 921045H; aaa) Primary I.V. Set, Nonvented, 72 Inch, list 150620448, lot 911565H; bbb) Latex-Free Primary I.V. Set, Convertible Pin, 84 Inch, list 151280478, lot 89116HG; ccc) Primary I.V. Set, Nonvented, 93 Inch, list 153550448, lot 960315H ddd) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch, list 153990458, lot 892035H; eee) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 154090448, lot 931085H; fff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch, list 170400478, lot 940695H; ggg) LifeShield Latex-Free Y-Type Anesthesia I.V. Set, Nonvented, 130 Inch, list 190580448, lot 87021HG; hhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 135 Inch, list 190920401, lots 86025HG, 89013HG; iii) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Piercing Pin, 112 Inch, list 191090448, lots 85047HG, 88078HG, 89108HG, 911625H; jjj) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch, list 191100448, lots 85048HG, 87014HG, 87151HG, 88059HG, 89053HG, 89122HG, 911635H, 931215H; kkk) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 111 Inch, list 191110448, lots 85156HG, 87152HG, 89065HG, 910785H, 930485H; lll) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch, list 191180448, lot 96019R5; mmm) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch, list 191330448, lots 03016R5, 93046R5, 94023R5, 95024R5; nnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 124 Inch, list 191370458, lots 86039HG, 87154HG, 89039HG, 941165H, 961255H; ooo) LifeShield Latex-Free Primary I.V. Set with Convertible Pin, list 191520448, lot 88134HG; ppp) LifeShield Latex-Free Primary Piggyback I.V. Set , Convertible Pin, list 192070448, lot 01021R5; qqq) LifeShield Latex-Free Primary I.V. Set, Convertible Piercing Pin, 147 Inch, list 192170448, lots 011425H, 87036HG, 88110HG; rrr) Latex-Free Primary I.V. Set, Convertible Pin, 82 Inch, list 192180448, lots 86142HG, 88095HG, 88170HG, 89111HG, 911085H, 941215H; sss) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch, list 192290448, lots 87134HG, 88096HG, 930445H; ttt) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 101 Inch, list 192410478, lots 88125HG, 88147HG, 891435H, 951525H; uuu) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 107 Inch, list 192530448, lot 86139HG; vvv) LifeShield Latex-Free Primary I.V. Set, Nonvented, 124 Inch, list 192600401, lot 911005H; zzz) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch, list 192620448, lot 960815H; aaaa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 141 Inch, list 192670448, lot 96020R5; bbbb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 126 Inch, list 192680448, lot 94019R5; cccc) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch, list 192770448, lots 020355H, 87020HG, 88111HG, 910815H, 930495H, 941055H, 950335H; dddd) LifeShield Latex-Free Primary I.V. Set, Nonvented, 127 Inch, list 192990448, lot 02057R5; eeee) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch, list 193110448, lots 87155HG, 960455H; ffff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch, list 193210448, lots 871365H, 921025H; gggg) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 111 Inch, list 193240448, lots 88079HG, 940255H hhhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 104 Inch, list 193260448, lot 931355H; iiii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 138 Inch, list 193270448, lots 88014HG, 88051HG, 930505H, 941585H; jjjj) LifeShield Latex-Free Primary I.V. Set, Nonvented, 102 Inch, list 193310448, lot 01025R5; kkkk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 136 Inch, list 193440448, lots 02023R5, 88026R5, 89026R5, 92033R5; llll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 136 Inch, list 193490448, lot 95026R5; mmmm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 109 Inch, list 193570448, lots 02022R5, 86146HG, 93027R5; nnnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 125 Inch, list 193590448, lot 88164HG, ****06039R5****; oooo) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch, list 195040448, lot 01032R5; pppp) Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch with 2 Injection Sites, Microdrip, list 017230478, lots 891965H, 950585H; qqqq) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch, list 193480448,lots 87038HG, 901605H; ****rrrr) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 93 inch, list 195180465, lot 14047R5**** Please note, item k, list 018810458, lot 910824W, was also case packed with Liposyn II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02, lot 92522DF, distributed by Abbott Laboratories, North Chicago, IL 60064
• 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: 18,560,003 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 = ABBOTT MFG., INC.; 510(K)s with Product Code = FPA and Original Applicant = OMNI-GLOW, INC.