Baxter Healthcare Corp.: 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.

Recall number

Z-2222-2011

Recalling firm

Baxter Healthcare Corp.

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.

Status

Terminated

Initiated

2011-04-14

Posted

2011-05-19

Terminated

2012-05-09

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K063696"]

PMA numbers

not on file

Product code

FRN

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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