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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter 6060 MultiTherapy Infusion Pump

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  Class 2 Device Recall Baxter 6060 MultiTherapy Infusion Pump see related information
Date Initiated by Firm December 17, 2003
Date Posted January 29, 2004
Recall Status1 Terminated 3 on November 28, 2006
Recall Number Z-0376-04
Recall Event ID 28037
510(K)Number K002679  
Product Classification unknown device name - Product Code FRN--
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
Code Information 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.
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Premature motor failure.
FDA Determined
Cause 2
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.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN-- and Original Applicant = BAXTER HEALTHCARE CORP.
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