WalkMed Recalls Triton FP Infusion Pumps Due to Labeling Error
WalkMed Infusion is recalling 797 Triton FP Infusion Pumps because the label on the right side contains an incorrect instruction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the defect as a labeling error containing an incorrect instruction. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
WalkMed Infusion, LLC is recalling 797 units of the Triton FP Infusion Pump, Part Number 400000. The recall was initiated because the label located on the right side of the pump contains an incorrect instruction.
The affected devices are distributed in the United States, specifically in the states of Illinois, Massachusetts, Kansas, and New Jersey. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, providing Total Parenteral Nutrition (TPN), and Patient Controlled Analgesia (PCA). It is intended for use in hospitals, ambulatory and nursing home settings, and home care environments.
Healthcare facilities and consumers who possess these devices should contact WalkMed Infusion for further instructions on how to proceed with the recall.
The recalled product
- Product
- Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in…
- Manufacturer
- WalkMed Infusion, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 797
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 (20)
- PFA14001
- PFA14002
- PFA14003
- PFA14004
- PFA14005
- PFA14006
- PFA14007
- PFA14008
- PFA14009
- PFA14010
- PFA14011
- PFA14012
- PFA14013
- PFA14014
- PFA14015
- PFA14016
- PFA14017
- PFA14018
- PFA14019
- PFA14020
Distribution
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