—#96447

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected lot / code info: Product Code 2M8161, serial numbers 12070599CC, *** 13122321CC, 12090836CC, 14100923CC, 17072414CC, 12050845CC, 15021879CC, 17051145CC, 13090799CC***; Product Code 2M9161, serial numbers 17086323CP, *** 17070451CP, 17091738CP, 17091071CP, 17082117CP ***;

Why it was recalled

The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.

Root cause (FDA determination)

Employee error

Action the firm took

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. ****

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide Distribution -- Arizona, Indiana, *** California, Iowa, New Jersey, Ohio, Virginia and West Virginia***.

Timeline

Recall initiated: 2010-12-01
Posted by FDA: 2011-01-21
Terminated: 2012-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.