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WalkMed Infusion, LLC recalls Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetri
Recalled November 18, 2015 · FDA recall Z-0242-2016 · WalkMed Infusion
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. · FDA Class II
Units
4695 units
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
WalkMed Infusion, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →