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

FDA device recall Z-2222-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

FRN

Quantity affected

117 pumps

Distribution

Worldwide distribution: USA (nationwide) including states of :Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Ca

Date initiated

2011-04-14

Date posted

2011-05-19

Date terminated

2012-05-09

Location

Round Lake, IL

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