Class 2 Device Recall Abbott, Abbott LifeShield & Abbott Venisystems Burette Sets

• Date Initiated by Firm: June 09, 2003
• Date Posted: June 27, 2003
• Recall Status: Terminated on August 27, 2004
• Recall Number: Z-0955-03
• Recall Event ID: 26450
• 510(K)Number: K832755 K913308 K915571 K920736 K941214
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Vented and Non-Vented Burette I.V. Gravity Feed Administration 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 250 mL Burette Set, Vented, 77 Inch Soluset, list 017170402, lot 88006DT; b) Latex-Free 100 mL Burette Set, Vented, 77 Inch Soluset, list 017260402, lot 88100HG; c) Latex-Free 150 mL Burette Set, Vented, 77 Inch, list 018820468, lot 921495H; d) Latex-Free 150 mL Burette Set, Vented, 100 Inch, list 066460401, lot 911755H; e) LifeShield Latex-Free 150 mL Burette Set, Vented, 100 Inch, list 113980401, lots 88073HG, 90014HG; f) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch, list 119640402, lots 88070HG, 88139HG, 89064HG, 90008HG, 921105H, 951025H; g) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 110 Inch, list 120720401, lot 90015HG; h) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch, list 123410401, lot 88081HG; i) LifeShield Latex-Free Inline Burette Set 150 mL, Nonvented, list 124250401, lots 85030HG, 88009HG, 88055HG, 910745H, 930175H; j) 150 mL Burette Set, Nonvented, 77 Inch, list 153630468, lot 931255H; k) Latex-Free 150 mL Burette Set, Nonvented, 77 Inch, list 153800468, lot 88068HG; l) LifeShield Latex-Free 150 mL Burette Set, Vented, 108 Inch, list 191890401, lot 89055HG m) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch, list 192080401, lots 87017HG, 87125HG, 891765H, 941045H, 961595H; n) Venisystems Soluset 150 x 15, list 0E4031301, lot 86100HG; o) LifeShield Latex-Free 150 mL Burette Set, Vented, Convertible Pin, 77 Inch, list 117440401, lots 88106HG, 930145H, 961465H
• 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: 178,243 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; 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA