—#31080

Product

Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

FDA product code: FRN--
510(k) numbers: K002679
Affected lot / code info: serial numbers 108050HR, 108183HR, 108298HR, 109036HR, 109216HR, 109622HR, 110004HR, 110700HR, 111126HR, 111270HR, 111540HR, 112441HR, 201178HR, 308361HR/308440HR, 309001HJ/309030HJ, 309001HR/309345HR 309001HW/309015HW, 310001HG/310010HG , 310001HW/310010HW , 310007HR/310088HR, and HR1976/HR27480. Only those pumps within these serial numbers with installed motor assemblies from date codes 33/03, 34/03 and 35/03 are affected.

Why it was recalled

Premature motor failure.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps.

Recalling firm

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

Distribution

Distribution pattern: The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.

Timeline

Recall initiated: 2003-12-17
Posted by FDA: 2004-01-29
Terminated: 2006-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #31080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.