Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. 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.
Recall
- Recall Number
- Z-0745-2012
- Event Number
- 60520
- Firm
- Baxter Healthcare Corp. Rt.
- FEI Number
- 1416980
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- July 14, 2010
- Posted
- January 13, 2012
- Terminated
- January 13, 2012
- Address
- 120 & Wilson Rd, Round Lake, IL, 60073
Description
Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. 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.
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.
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.
Nationwide distribution: Puerto Rico.
1 unit