Recall Z-0242-2016 ยท FRN Pump, Infusion
WalkMed Infusion, LLC
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.
| Date | Nov 6, 2015 (initiated Oct 1, 2015) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP Definitive Medical Technologies, Ltd., May 8, 2007 |