—#99634

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-04-14
Posted by FDA: 2011-05-19
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.