Recall Z-2220-2016— WalkMed Infusion, LLC
Class II · Terminated
Class II FDA medical device recall by WalkMed Infusion, LLC, initiated 2016-06-14, terminated 2017-04-28. It names one FDA 510(k) clearance: K070529. Product: The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.. Reason: WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000)..
- Recalling firm
- WalkMed Infusion, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-14
- Terminated
- 2017-04-28
- 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
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Reason for recall
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).
Data sourced from openFDA. This site is unofficial and independent of the FDA.