The pump — Class II medical device recall Z-2219-2016
Terminated recall by WalkMed Infusion, LLC, reported 2016-07-27, distributed nationwide. WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton
| Recall number | Z-2219-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WalkMed Infusion, LLC, Englewood, CO, United States |
| Recall initiated | 2016-06-14 |
| Classified | 2016-07-18 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,482 units |
| Reason classes | software, unapproved 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.
Reason for recall
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2219-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.