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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague CX and CXE Infusion Pumps

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 Class 2 Recall
Colleague CX and CXE Infusion Pumps
see related information
Date Posted January 21, 2011
Recall Status1 Terminated on January 20, 2012
Recall Number Z-0935-2011
Recall Event ID 57516
Premarket Notification
510(K) Number
K063696 
Product Classification Pump, Infusion - Product Code FRN
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
Manufacturer Reason
for Recall
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
FDA Determined
Cause 2
TRAINING: Employee Error
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***.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
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