Z-0242-2016Class II

Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark...

Name: Z-0242-2016 Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark...
Creator: WalkMed Infusion, LLC
Published: 2015-10-01
License: https://open.fda.gov/license/

WalkMed Technologies, LLC / initiated 2015-10-01 / Terminated / root cause: design

FDA source

WalkMed Infusion, LLC began a recall of Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids... on 2015-10-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0242-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-01
Posted: 2015-11-06
Terminated: 2016-07-12
Recalling firm: WalkMed Technologies, LLC
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.
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 4695 units
Distribution: 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.
Product codes and lots: Model numbers 300000, 400000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0242-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0242-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code FRN

K070529Class IIAff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd. / cleared 2007-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)