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 22, 2011
- Posted
- August 8, 2011
- Terminated
- February 14, 2012
- Recall Number
- Z-2958-2011
- Quantity
- 1 unit
- Firm Location
- Round Lake, IL
Reason for Recall
Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications
Distribution
(USA) Nationwide Distribution including the state of Minnesota.
Lot / Code Info
Product Code: 2M8161, Serial Number 12020525CC
Root Cause
Other
Action Taken
Baxter Healthcare Corp. notified the consignee by telephoned on July 22, 2011, with the call documented per the approved call script. A follow-up "URGENT PRODUCT RECALL" notification was sent dated July 25, 2011, reiterating the telephone communication informing them that the COLLEAGUE pump may not have met certain PSIG (Pounds-force per Square Inch) specifications after testing by the Baxter Global Technical Service Center. Both forms of notification identified the affected product, problem description, hazard involved, and actions needed to be taken. The consignee was instructed to locate the device, remove it from service and return it to Baxter by contacting Baxter Global Technical Services at 1-800-843-7867 option 1, to obtain a prepaid UPS label and shipping box. Upon receipt of the returned unit, Baxter will perform the required testing and address any issues through repair or service. The notication instructs the consignee to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter as per the instructions provided. If the recalled product have been distributed to another facility, or if you are a dealers, wholesalers and distributors, the letter request that this communication be forward to the pump owner as appropriate. For any questions regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central time.