| Class 2 Device Recall Colleague CX and CXE Infusion Pumps | |
Date Initiated by Firm | December 01, 2010 |
Date Posted | January 21, 2011 |
Recall Status1 |
Terminated 3 on January 20, 2012 |
Recall Number | Z-0935-2011 |
Recall Event ID |
57516 |
510(K)Number | K063696 |
Product Classification |
Infusion Pump - Product Code FRN
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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 IL 60073
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FRN
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