Z-0632-2007

Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare...

Name: Z-0632-2007 Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare...
Creator: Baxter Healthcare Corp.
Published: 2006-11-27
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2006-11-27 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 on 2006-11-27. The reason FDA records is "There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0632-2007
Status: Terminated
Initiated: 2006-11-27
Posted: 2007-03-20
Terminated: 2010-01-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: FRN Pump, Infusion
Reason for recall: There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.
FDA root cause: Other
Action: Baxter sent the 11/27/06 Urgent Device Correction letter to all Flo-Gard Volumetric Infusion Pump customers, to the attention of the Vice President of Nursing and the Biomedical Engineer, via first class mail to alert them to the potential for non-detection of, and no alarm for, upstream occlusion under specific conditions for Flo-Gard Volumetric Infusion Pumps if the occlusion occurs above a flexible chamber (such as a drip chamber, Buretrol or blood filter), and to provide the addendum to the operator manual to address these specific conditions. The letters included the mitigations and risks associated with each of the conditions that could potentially cause this situation. This information was included in the letter, as well as the Operator''s Manual Addendum, which Baxter requested to attach a copy to all Flo-Gard Operator''s Manuals in their facility. Baxter instructed the customers to share this information with all staff members, services and facilities that use Flo-Gard pumps. Any questions were directed to Baxter''s Global Technical Services at 1-800-843-7867, prompt 2. Although Baxter previously notified customers on 3/5/99 that they would no longer support or service the Flo-Gard 6200 and 6300 devices as of 12/1/99, these product codes were included in this letter due to a similar potential for this issue. Should the customer still have these 6200 or 6300 devices in their possession, Baxter recommended that they be taken out of service due to obsolescence of the appropriate components. The accounts were requested complete the enclosed reply form acknowledging receipt of the letter and dissemination of the information to their staff.
Quantity in commerce: 177,468 pumps
Distribution: Worldwide including USA, Puerto Rico, Argentina, Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Honduras, India, Indonesia, Ireland, Italy, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Singapore, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
Product codes and lots: all serial numbers

Product code FRN

K915522Class IIFlo-Gard(r) 6201Baxter Healthcare Corp / cleared 1992-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)