Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- May 4, 2011
- Posted
- July 13, 2011
- Terminated
- January 10, 2017
- Recall Number
- Z-2796-2011
- Quantity
- 12 pumps
- Firm Location
- Round Lake, IL
Reason for Recall
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
Distribution
Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and Puerto Rico.
Lot / Code Info
Product Code 2 M8153, serial numbers 9070872CT and 12120279CT; Product Code 2M8163, serial numbers 14082199TC, 14090543TC, 13120195TC, 13120172TC, 13100660TC, 15041195TC, 11120467TC, 14082067TC, 12010398TC and 12010355TC
Root Cause
Employee error
Action Taken
Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps 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 coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost. Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.