WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes
WalkMed Infusion is voluntarily recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.
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, and the hazard involves unapproved changes to a medical device's software and intended use, which poses a risk of harm even though no injuries or illnesses are reported in the source text.
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 action is being taken because of unapproved changes to the software and specifications of the Triton Infusion Pump, as well as unapproved changes to the intended use of the Triton FP Infusion Pump.
The recall involves 2,482 units of the affected pumps. These devices were distributed nationwide to facilities in Alabama, Arizona, California, Florida, Illinois, Kansas, Massachusetts, Maryland, Mississippi, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Washington. The source text does not specify any reported illnesses, injuries, or deaths associated with these unapproved changes.
Healthcare facilities and consumers should check their inventory for the specific model numbers and lot codes listed in the official recall notice. If a device is affected, it should be removed from service and returned to WalkMed Infusion, LLC according to the instructions provided by the manufacturer.
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
- 2,482
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)
- TR1041
- TR1043
- TR1044
- TR1047
- TR1049
- TR1051
- TR1053
- TR1054
- TR1055
- TR1056
- TR1058
- TR1059
- TR1060
- TR1061
- TR1062
- TR1063
- TR1064
- TR1065
- TR1066
- TR1067
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
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