FDAFDA · Food and drugs·Recall number Z-2348-2024
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Published July 24, 2024 · Recall initiated: April 30, 2024
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
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St. Jude Medical
- Distributor
- US and Canada
- Lot
- UDI/DI 05414734206099, Lot Number 10071090
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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