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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model numbers 300000, 400000
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- WalkMed Infusion, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
Model numbers 300000, 400000
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0242-2016
Related Recalls
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
WalkMed Infusion
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).
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.