—#32786

Product

Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002211, K003616
Affected lot / code info: product code 2M8163 - serial numbers 12030001TC and above

Why it was recalled

Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Baxter sent urgent device correction letters dated 4/13/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the ink deterioration of the letters, numbers and symbols on the Colleague Volumetric Infusion Pump programming and pump channel keypads, and informed them that over time such ink deterioration may impact legibility of the keys. The letters provided a listing of model numbers and serial numbers of pumps at their facility which may have potentially affected keypads. The accounts were given a sample of the overlay to be applied over the programming keypad and installation instructions as an interim fix while replacement keypads are obtained and installed as the pumps are processed through their depot repair centers. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of overlays needed. Any questions were directed to Baxter at 1-800-843-7867. On 6/9/05, Baxter sent Urgent Device Correction letters to the accounts, to the attention of the Director of Biomedical Engineering, advising them that the replacement pump programming and pump channel keypads were now available.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.

Timeline

Recall initiated: 2004-04-13
Posted by FDA: 2004-07-20
Terminated: 2011-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.