—#49482

Product

Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915523
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-11-27
Posted by FDA: 2007-03-20
Terminated: 2010-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.