Z-3007-2011

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation...

Name: Z-3007-2011 Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation...
Creator: Baxter Healthcare Corp.
Published: 2011-07-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-07-22 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. Intended for... on 2011-07-22. The reason FDA records is "The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3007-2011
Status: Terminated
Initiated: 2011-07-22
Posted: 2011-08-11
Terminated: 2011-11-09
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Product code: FRN Pump, Infusion
Reason for recall: The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump; promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to [email protected], and forward this communication to the pump owner as appropriate, if they distributed the pump to another facility or if they are dealers, wholesalers, or distributors/resellers. The letter states "Upon receipt of the returned device, Baxter will perform required testing on the affected COLLEAGUE pump for which you have indicated there is continuing medical necessity. Should Baxter find any issues during testing, Baxter will address those issues through repair or service prior to returning the pump to you at no charge". If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.
Quantity in commerce: 1 Pump
Distribution: Nationwide distribution: MN only.
Product codes and lots: Product Code: 2M8161, Serial Number 12010746CC

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)