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

Recall number

Z-1111-2007

Recalling firm

Baxter Healthcare Corp.

Product

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

Status

Terminated

Initiated

2007-06-21

Posted

2007-07-28

Terminated

2010-03-16

Reason

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

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

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

Lot, serial or model codes

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.

510(k) numbers

["K915522"]

PMA numbers

not on file

Product code

FRN

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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