Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication D

FDA device recall Z-2853-2011 · posted 2011-07-19 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.

Action taken

Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up "URGENT PRODUCT RECALL" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

2 units

Distribution

Nationwide (USA) Distribution -- including the state of Pennsylvania.

Date initiated

2011-07-05

Date posted

2011-07-19

Date terminated

2012-01-20

Location

Round Lake, IL

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