Class 2 Device Recall Baxter 6060 Solution Sets with AutoClamp

• Date Initiated by Firm: November 19, 2004
• Date Posted: January 08, 2005
• Recall Status: Terminated on June 28, 2006
• Recall Number: Z-0385-05
• Recall Event ID: 30506
• 510(K)Number: K002679
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., the following sets were made in Costa Rica: a) Baxter Solution Set, 76'' (1.9 m), Volume 3.7 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9856 and 2M9856K; b) Baxter Solution Set, 109'' (2.8 m), Volume 4.8 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9857; c) Baxter Solution Set, 112'' (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9858 and 2M9858K; d) Baxter Solution Set, 112'' (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9859; e) Baxter Solution Set, 76'' (1.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9860; f) Baxter Solution Set, 112'' (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9861; g) Baxter Solution Set, 112'' (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9862; h) Baxter Solution Set, 111'' (2.9 m), Volume 7.4 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapters, product code 2M9874K; i) Baxter Solution Set, 75'' (1.9 m), Volume 3.1 mL, Cassette with AutoClamp Device, Male Luer Lock Adapters, product code 2M9875K; j) Baxter Epidural Set, 115'' (2.9 m), Volume 5.0 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9003; k) Baxter Epidural Set, 112'' (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2L9004; l) Baxter Epidural Set, 92'' (2.3 m), Volume 6.7 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapters, product code 2L9005; m) Baxter Solution Set with Spike, 88'' (2.2 m), Volume 4.1 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9006
• Code Information: Product codes 2M9859, 2M9856, 2M9856K, 2M9857, 2M9858, 2M9858K, 2M9860, 2M9861, 2M9862, 2M9874K, 2M9875K, 2L9003, 2L9004, 2L9005, 2L9006; all sets with lot numbers below R03K25200. The lot number R03XXXXXX (format RYYMDDNNC) is broken down as follows: R = manufacturing plant location; YY = numeric year (01, 02, 03); M = alpha month, A = January through L = December; DD = numeric day of month; NN = numeric batch number for the day, 01 - 99; C = numeric check digit generated by computer.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
• FDA Determined Cause: Other
• Action: Urgent Product Recall letters dated 11/19/04 were sent to the direct accounts on the same date via UPS ground. The accounts were informed that free-flow situations were associated with the listed product codes and lot numbers due to a missing platen assembly in the cassette of the solution sets, which could result in an overdose of medication to the patient. The accounts were requested to stop use of the affected lot numbers and product codes and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. Any questions concerning the return process were directed to NCC at 1-866-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837.
• Quantity in Commerce: 3,063,359 sets
• Distribution: Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
• 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