Recall Z-0242-2016— WalkMed Infusion, LLC
Class II · Terminated
Class II FDA medical device recall by WalkMed Infusion, LLC, initiated 2015-10-01, terminated 2016-07-12. It names one FDA 510(k) clearance: K070529. 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..
- Recalling firm
- WalkMed Infusion, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-01
- Terminated
- 2016-07-12
- Firm location
- Englewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.