Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0376-04

Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter...

Baxter Healthcare Corporation / initiated 2003-12-17 / Terminated

Baxter Healthcare Corp. began a recall of Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in... on . The reason FDA records is "Premature motor failure". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0376-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
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
Product code
FRN--
Reason for recall
Premature motor failure.
FDA root cause
Other
Action
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.
Quantity in commerce
188 units
Distribution
The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.
Product codes and lots
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.