—#53174

Product

Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915522
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2007-06-21
Posted by FDA: 2007-07-28
Terminated: 2010-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53174. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.