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Terminated

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.

FDA Recall Z-0598-2012 · Posted 2012-01-11

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-05-08
Date Terminated2012-01-03
Product Quantityone pump

Reason for Recall

There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

Firm Action

Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.

Root Cause

Process control

Distribution Pattern

Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063696COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163Baxterhealthcare, Inc. · 2007-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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