WalkMed Infusion Pumps Recalled for Air Detection Failure
WalkMed Infusion is recalling Triton Infusion Pumps because they may fail to detect air in the line when infusing Venofer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (air in line) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
WalkMed Infusion, LLC is recalling 4,695 units of Triton Infusion Pumps (model 300000) and Triton fp Infusion Pumps (model 400000). These devices are used to pump fluids into patients in a controlled manner.
The recall was initiated because the devices might fail to detect air in the line while infusing the medication Venofer. This failure 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.
The affected units were 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. Users should contact WalkMed Infusion for further instructions.
The recalled product
- 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
- WalkMed Infusion, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 4,695
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model numbers 300000
- 400000
Distribution
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