Recall Z-0633-2007 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Mar 20, 2007 (initiated Nov 27, 2006) |
| Status | Terminated |
| Reason | 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 | 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 risk |
| Quantity | 42,098 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 Zealan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915523 | FLO-GARD(R) 6301 Baxter Healthcare Corp, Feb 28, 1992 |