Z-2222-2011

Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps...

Name: Z-2222-2011 Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps...
Creator: Baxter Healthcare Corp.
Published: 2011-04-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-04-14 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery... on 2011-04-14. The reason FDA records is "The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user". 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-2222-2011
Status: Terminated
Initiated: 2011-04-14
Posted: 2011-05-19
Terminated: 2012-05-09
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 and 2M9161. 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 Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Baxter Healthcare Corporation, telephoned the customers on April 14, 2011, informing them that that the Hi-Pot test,and sent a follow up "URGENT DEVICE CORRECTION" letter dated April 27, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the pumps and take them out of service as soon as possible (Baxter will then send a shipping container for retrieval, re-inspection and return of the device back to the customer at no cost.); and return their colleague pumps for full functional testing including the HiPot test to the Baxter Buffalo Grove Global Technical Services (GTS) Center at Baxter GTS, 900 Corporate Grove Drive, Buffalo Grove, IL 60089. Baxter will perform full functional testing, including the HiPot test, on affected Colleague pumps for which the customer has continuing medical necessity. Should Baxter identify any issues through repair or service prior to returning the Colleague pumps to the customer. If you have 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 CT, Monday through Friday.
Quantity in commerce: 117 pumps
Distribution: Worldwide distribution: USA (nationwide) including states of :Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia, and country of: Canada.
Product codes and lots: Product code: 2M8151, Serial numbers 10090647CS, 10115635CS, 10115962CS, 10116082CS, 10116632CS, 10121619CS, 11011446CS, 11013479CS, 11030809CS, 11050013CS, 11050408CS, 11080071CS, 11080504CS, 11080881CS, 11081127CS, 11081178CS, 11081341CS, 11081358CS, 11081693CS, 11091827CS, 12010687CS and RA01705CS * Product code: 2M8161, Serial numbers 11120207CC, 11120577CC, 11120679CC, 11121015CC, 11121486CC, 11121539CC, 12030561CC, 12030888CC, 12030893CC, 12041367CC, 12041749CC, 12050038CC, 12050219CC, 12050223CC, 12050664CC, 12050681CC, 12051057CC, 12090119CC, 12090405CC, 12090427CC, 12091053CC, 12091075CC, 12091148CC, 12091405CC, 12091556CC, 12100117CC, 12100982CC, 12101088CC, 12101206CC, 12101594CC, 12101640CC, 12101697CC, 13010436CC, 13010685CC, 13021534CC, 13030933CC, 13040553CC, 13040621CC, 13040858CC, 13040959CC, 13050740CC, 13050540CC, 13070265CC, 13070294CC, 13071355CC, 13080673CC, 13090662CC, 13100920CC, 13101054CC, 13101261CC, 13110978CC, 13120218CC, 13121245CC, 13121377CC, 13121543CC, 13121871CC, 13122235CC, 13122390CC, 13123119CC, 13124082CC, 14040190CC, 14040232CC, 14040382CC, 14040631CC, 14051452CC, 14062542CC, 14073731CC, 14092140CC, 14100120CC, 14101408CC, 14110357CC, 14112103CC, 14120740CC, 14120849CC, 14121202CC, 14121225CC, 14121577CC, 14121865CC, 14123040CC, 14124070CC, 15033184CC, 15050130CC, 15060217CC, 15072249CC, 15072698CC, 15072852CC, 15081325CC, 15084164CC, 15092830CC, 15102333CC and 17110473CC, Product code 2M9161, Serial numbers 17040756CP, 7041105CP, 17085496CP and 17088142CP

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)