—#36017

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;

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002679
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland

Timeline

Recall initiated: 2004-11-19
Posted by FDA: 2005-01-08
Terminated: 2006-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.