—#102819

Product

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. 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: 2M8161, Serial Number 12010746CC

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: MN only.

Timeline

Recall initiated: 2011-07-22
Posted by FDA: 2011-08-11
Terminated: 2011-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102819. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.