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 Recall Z-0935-2011 · Posted 2011-01-21
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-12-01
Date Terminated2012-01-20
Product Quantity14 pumps
Reason for Recall
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
Firm 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. ****
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution -- Arizona, Indiana, *** California, Iowa, New Jersey, Ohio, Virginia and West Virginia***.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.