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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Colleague CX and CXE Infusion Pumps		see related information
Date Posted January 21, 2011
Recall Number Z-0935-2011
Product Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
Code Information Product Code 2M8161, serial numbers 12070599CC, *** 13122321CC, 12090836CC, 14100923CC, 17072414CC, 12050845CC, 15021879CC, 17051145CC, 13090799CC***; Product Code 2M9161, serial numbers 17086323CP, *** 17070451CP, 17091738CP, 17091071CP, 17082117CP ***;
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Reason for
Recall		 The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
Action Baxter telephoned the two customers on December 1, 2010, informing them that that a post repair test was not performed correctly on their Colleague pumps (serial numbers 12070599CC and 17086323CP) during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them 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. *** Baxter expanded the recall to include twelve additional pumps on June 22, 2011 by telephone calls to the affected accounts. The recall strategy remains the same as the December 1, 2010 instructions. ****.
Quantity in Commerce 14 pumps
Distribution Nationwide Distribution -- Arizona, Indiana, *** California, Iowa, New Jersey, Ohio, Virginia and West Virginia***.
 
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