Recall Z-1122-2014— WalkMed Infusion, LLC
Class II · Terminated
Class II FDA medical device recall by WalkMed Infusion, LLC, initiated 2014-02-17, terminated 2014-10-06. It names one FDA 510(k) clearance: K070529. Product: 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.. 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..
- Recalling firm
- WalkMed Infusion, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-17
- Terminated
- 2014-10-06
- 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 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.