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U.S. Department of Health and Human Services

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 Class 2 Recall
Colleague CX Volumetric Infusion Pump
see related information
Date Posted January 21, 2011
Recall Number Z-0931-2011
Product Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
Code Information Product Code: 2M8161, serial number 15030799CC
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Center for One Baxter
800-422-9837
Reason for
Recall
While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
Action Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.
Quantity in Commerce 1 pump
Distribution Texas
 
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