Z-1224-2007

Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication...

Name: Z-1224-2007 Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication...
Creator: Baxter Healthcare Corp.
Published: 2007-08-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2007-08-15 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in... on 2007-08-15. The reason FDA records is "Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1224-2007
Status: Terminated
Initiated: 2007-08-15
Posted: 2007-09-19
Terminated: 2008-02-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161
Product code: FRN Pump, Infusion
Reason for recall: Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
FDA root cause: Other
Action: The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.
Quantity in commerce: 42 pumps
Distribution: Florida and California
Product codes and lots: product code 2M8161, serial numbers 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC

Product code FRN

K063696Class IIColleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163Baxterhealthcare, Inc. / cleared 2007-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)