Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Med

FDA device recall Z-0935-2011 · posted 2011-01-21 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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

Action taken

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. ****

Root cause

Employee error

Status

Terminated

Product code

FRN

Quantity affected

14 pumps

Distribution

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

Date initiated

2010-12-01

Date posted

2011-01-21

Date terminated

2012-01-20

Location

Round Lake, IL

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