Epidural 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.
FDA Recall Z-1592-05 · Posted 2005-09-28
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2005-08-17
Date Terminated2007-06-19
Reason for Recall
Potential overinfusion in the Auto-Ramp mode with software versions 3.00 or higher
Firm Action
Baxter 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.
Root Cause
Other
Distribution Pattern
Nationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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