FDAFDA · Food and drugs·Recall number Z-0242-2016
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.
Published November 18, 2015 · Recall initiated: October 1, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- WalkMed Infusion, LLC
- Distributor
- 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.
- Lot
- Model numbers 300000, 400000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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