RecallDepth

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161

Company
Baxter Healthcare Corp. Rt
Recall Initiated
July 22, 2011
Posted
August 11, 2011
Terminated
October 19, 2011
Recall Number
Z-3008-2011
Quantity
1 pump
Firm Location
Round Lake, IL

Reason for Recall

A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.

Distribution

Nationwide distribution: Missouri only.

Lot / Code Info

Product Code: 2M8161, Serial Number 12091459CC

Root Cause

Other

Action Taken

The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com. If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.

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