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Terminated

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 Recall Z-2796-2011 · Posted 2011-07-13

Recall StatusTerminated
Product CodeFRN
Date Initiated2011-05-04
Date Terminated2017-01-10
Product Quantity12 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 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.

Root Cause

Employee error

Distribution Pattern

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

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.

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