Reported Nov 18, 2015 · Terminated
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I)…
WalkMed Infusion, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WalkMed Infusion, LLC · 6555 S Kenton St Ste 304 · Englewood, CO · 80111-6838
Is this the product you have?
- Triton Infusion Pump (model 300000) and Triton fp Infusion
- Pump (model 400000) (proprietary nameAFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner
- Lot codes and dates
Model numbers 300000400000
- Amount recalled
- 4695 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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