Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield,

FDA device recall Z-0882-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Distribution

Nationwide, and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Ara

Date initiated

2004-04-13

Date posted

2004-07-20

Date terminated

2011-02-02

Location

Round Lake, IL

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