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.
FDA Recall Z-0242-2016 · Posted 2015-11-06
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Recalling FirmWalkMed Infusion, LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2015-10-01
Date Terminated2016-07-12
Product Quantity4695 units
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.
Firm Action
A Field Notification (letter) was provided to users on 10/01/15 to remind them of the following:use air elimination filters, as appropriate, not to over program into the device the volume to be infused, remove air from the IV bag prior to starting the infusion, issues associated with the use of Venofer or similar drugs. No products are being returned.
Root Cause
Device Design
Distribution Pattern
Distributed in the states of AL, CA, CO, DE, FL, GA, IL, MA, MD, MI, MN, MS, NC, NJ, NM, NV, NY, OH, PA, TN, TX, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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