Recall Z-1122-2014 ยท FRN Pump, Infusion
WalkMed Infusion, LLC
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
| Date | Mar 3, 2014 (initiated Feb 17, 2014) |
| Status | Terminated |
| Reason | WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction. |
| Root cause | Labeling design |
| Action | WalkMed Infusion sent an Important Medical Device Recall letter dated February 14, 2014, to all affected customers. The letter identified the product the problem and the action customers need to take. Our records Indicate that you have purchased product affected by this recall (see the attached list).Our sales representative will contact you to determine a plan for label replacement for your units. Replacement of the label will include a simple process of removing the old label (PN 300063), replacing it with a corrected label(PN 400033) and documenting completion of the replacement. This acti |
| Quantity | 797 |
| Distribution | US Distribution including the states of IL, MA, KS, and, NJ. |
| 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 |