FDA-Device2015-11-18Class II
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
WalkMed Infusion, LLC
Hazard
The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.
Sold states
Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.
Affected count
4695 units
Manufactured in
6555 S Kenton St Ste 304, N/A, Englewood, CO, United States
Products
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2016Don't want to check this manually?
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