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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter 6060E & Sabratek 6060 Epidural Infusion Pumps

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 Class 2 Device Recall Baxter 6060E & Sabratek 6060 Epidural Infusion Pumpssee related information
Date Initiated by FirmAugust 17, 2005
Date PostedSeptember 28, 2005
Recall Status1 Terminated 3 on June 19, 2007
Recall NumberZ-1592-05
Recall Event ID 33032
510(K)NumberK941984 K002679 
Product Classification Pump, Infusion - Product Code FRN
ProductEpidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore b) Sabratek 6060 Epidural Pain Management Pump, product codes 606000-40E and 606000-40EL; Manufactured by Sabratek Corp., Skokie, IL 60076, which was purchased by Baxter Healthcare Corp., Deerfield, IL in January 2000.
Code Information product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers
FEI Number 1416980
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
FDA Determined
Cause 2		Other
ActionBaxter sent the 8/17/05 Urgent Product Recall letter to all Baxter 6060E Infusion Pump customers to inform them of a software anomaly present in software versions 3.00 and higher, which allows the pump to overinfuse in the Auto-Ramp mode. The end users were also informed that these epidural pumps, identified by the yellow housing, can no longer be supported due to a lack of availability of spare parts and Baxter is unable to replace the software with an alternate version. As a result, Baxter requested the accounts to remove the pumps from service and return them to Baxter. The accounts were requested to call Baxter''s Medication Delivery Services at 1-800-843-7867 to arrange for the return of the units and replacement with 6060 Multi-Therapy Infusion Pumps.
DistributionNationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = FRN
510(K)s with Product Code = FRN
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