FDA Device recall Z-0242-2016
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump)
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump) by Walkmed Infusion, citing the device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0242-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-01 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Walkmed Infusion |
| Distribution | AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, WA |
Product
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Reason
The device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the actual bag volume.
Identifiers
| code_info | Model numbers 300000, 400000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0242-2016%22
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