Food, drugs, devices › WalkMed Infusion, LLC
Device recall: Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for del
WalkMed Infusion, LLC (Englewood, CO) initiated this device recall on 17 Feb 2014; FDA lists 1 product record under event 67545, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 6 Oct 2014. Initiation: voluntary: firm initiated. WalkMed Infusion, LLC has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
WalkMed Infusion, LLC, Englewood, CO.
Reason for recall
"WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction."
Distribution
"US Distribution including the states of IL, MA, KS, and, NJ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1122-2014 | 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 hospitals, ambulatory & nursing home (extended… | 797 | Class II | Terminated | 12 Mar 2014 |
Context
Other enforcement events for WalkMed Infusion, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jun 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper | Device | Class II | 2 |
| 14 Jun 2016 | Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer | Device | Class II | 15 |
| 1 Oct 2015 | Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetri | Device | Class II | 1 |
All 4 events for WalkMed Infusion, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of IL, MA, KS, and, NJ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.