WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes
WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.
What this means for you
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 a voluntary field action for unapproved changes to software and specifications without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
WalkMed Infusion, LLC is conducting a voluntary field action for the Triton Infusion Pump (model 300000) and the Triton FP Infusion Pump (model 400000). The recall is due to unapproved changes to the software and specifications of the Triton Infusion Pump and unapproved changes to the intended use of the Triton FP Infusion Pump.
A total of 2,966 units are affected. These devices were distributed nationwide to Alabama, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Maryland, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Washington. The source text does not specify foreign, VA, government, or military distribution.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any specific injuries or illnesses associated with the unapproved changes.
The recalled product
- Product
- The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
- Manufacturer
- WalkMed Infusion, LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 2,966
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)
- PCF15045R
- PFA13002
- PFA13005
- PFA13006
- PFA13007
- PFA13008
- PFA13009
- PFA13010
- PFA13011
- PFA13012
- PFA13013
- PFA13014
- PFA13015
- PFA13016
- PFA13017
- PFA13018
- PFA13019
- PFA13020
- PFA13021
- PFA13022
Distribution
Part of a larger recall action
This product is one of 2 recalled by WalkMed Infusion, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · WalkMed Infusion, LLC
See all →- HighWalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
- HighWalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
FDA (Devices) · 2016-07-27
Same hazard · unapproved software
See all →- ModerateASPIRE Cristalle mammography systems shipped with unapproved slabbing software enabled
FDA (Devices) · 2025-08-06
- HighPhilips eCareManager versions recalled due to unapproved Sentry Score software
FDA (Devices) · 2022-02-09
- ModerateBoston Scientific LATITUDE Programming System Software Update Recall
FDA (Devices) · 2020-03-25
- HighBoston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software
FDA (Devices) · 2020-03-25
- ModerateMindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features
FDA (Devices) · 2019-11-06