Class 1 Device Recall Baxter FloGard 6201 Volumetric Infusion Pumps

• Date Initiated by Firm: June 21, 2007
• Date Posted: July 28, 2007
• Recall Status: Terminated on March 16, 2010
• Recall Number: Z-1111-2007
• Recall Event ID: 38221
• 510(K)Number: K915522
• Product Classification: Infusion Pumps - Product Code FRN
• Product: Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063
• Code Information: product code 2M8063, serial numbers 312424FB, 401424FB, 402089FB, 405111FB, 406060FB, 406067FB, 406154FB, 406155FB, 410334FB, 504036FB, 504053FB, 504061FB, 504378FB, 505328FB, 5090200FB, 5120672FB, 5120673FB, 6010044FB, 6050216FB, 7090392FB, 72000920, 72002220, 7202164Y, 7202357Y, 73041636, 73043106, 73044076, 73045746, 73048047, 73048607, 8070182FB, 93001467, 93007507, 10010241FB, 10100618FB, 10100652FB, 11010414FB, 11030373FB, 11050043FB, 11050487FB, 11050505FB, 11060149FB, 12060080FB, 13020041FB, 13040040FB, 13090060FB, 14020080FB, 13050172FB, 14080040FB.
• 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: Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
• FDA Determined Cause: Other
• Action: Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing. *** Baxter expanded the recall and telephoned the direct accounts starting on 7/30/07, informing them that the electrical safety testing may not have been performed on their Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required electrical safety and all functional verification testing. Follow-up recall letters were sent to the accounts on 8/7/07 reiterating the telephone conversations and providing a list affected pump serial numbers to be removed from service and returned to Baxter for testing. They were also requested to report any malfunction or adverse event related to the Colleague or Flo-Gard Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176. ****Recall 2 Extension******* Baxter expanded the recall for a second time via letter on 8/20/07 and telephone calls starting on 8/21/07, informing the direct accounts that Baxter's investigation found documentation inconsistencies by three more of their service technicians, representing the possibility of incomplete testing and/or documentation by these technicians who serviced Colleague infusion pumps at the account's facility. Without complete and properly do
• Quantity in Commerce: 49 units
• Distribution: Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
• 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