—#100335

Product

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected 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

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 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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and Puerto Rico.

Timeline

Recall initiated: 2011-05-04
Posted by FDA: 2011-07-13
Terminated: 2017-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.