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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
