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 Recall Z-0385-05 · Posted 2005-01-08
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2004-11-19
Date Terminated2006-06-28
Product Quantity3,063,359 sets
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.