Recall Z-2853-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. Product Usage: 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 r
| Date | Jul 19, 2011 (initiated Jul 5, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 returnin |
| Quantity | 2 units |
| Distribution | Nationwide (USA) Distribution -- including the state of Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063696 | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 Baxterhealthcare, Inc., Feb 27, 2007 |