FDAFDA · Food and drugs·Recall number Z-1543-2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Published April 24, 2024 · Recall initiated: December 19, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- Lot Numbers: P0407365, P0486670, P0561740
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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