Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. 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 routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- July 14, 2010
- Posted
- January 13, 2012
- Terminated
- January 13, 2012
- Recall Number
- Z-0744-2012
- Quantity
- 2 units
- Firm Location
- Round Lake, IL
Reason for Recall
Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system.
Distribution
Nationwide distribution: Puerto Rico.
Lot / Code Info
Product Code: 2M8161, Serial Numbers 15051625CC, 15020263CC
Root Cause
Employee error
Action Taken
Baxter sent service technicians to the consignees location on July 14, 2010 and October 6, 2010 and conducted the ground impedance and leakage current test on the affected pumps. The pumps were found with specifications.
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