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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague, Colleague CX and Colleague CXE Infusion Pumps

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 Class 2 Recall
Colleague, Colleague CX and Colleague CXE Infusion Pumps
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on May 09, 2012
Recall Number Z-2222-2011
Recall Event ID 58586
Premarket Notification
510(K) Number
K063696 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information 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
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2
TRAINING: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
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