Class 2 Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps

• Date Initiated by Firm: December 06, 2006
• Date Posted: January 11, 2007
• Recall Status: Terminated on June 30, 2011
• Recall Number: Z-0484-2007
• Recall Event ID: 36928
• 510(K)Number: K041191
• Product Classification: Infusion Pumps - Product Code FRN
• Product: Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R
• Code Information: All serial numbers used in or near linear accelerator suites
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
• FDA Determined Cause: Other
• Action: Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.
• Quantity in Commerce: 80,212 pumps
• Distribution: Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN