Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL

FDA device recall Z-3007-2011 · posted 2011-08-11 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.

Action taken

The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump; promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com, and forward this communication to the pump owner as appropriate, if they distributed the pump to another facility or if they are dealers, wholesalers, or distributors/resellers. The letter states "Upon receipt of the returned device, Baxter will perform required testing on the affected COLLEAGUE pump for which you have indicated there is continuing medical necessity. Should Baxter find any issues during testing, Baxter will address those issues through repair or service prior to returning the pump to you at no charge". If you have any 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 Central Time.

Root cause

Process design

Status

Terminated

Product code

FRN

Quantity affected

1 Pump

Distribution

Nationwide distribution: MN only.

Date initiated

2011-07-22

Date posted

2011-08-11

Date terminated

2011-11-09

Location

Round Lake, IL

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