FDAFDA · Food and drugs·Recall number Z-1800-2024
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Published May 22, 2024 · Recall initiated: March 19, 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
Potential for unsealed sterile packing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- Worldwide distribution.
- Lot
- a) Model Number 24009, GTIN 00673978178646, Lot Numbers: 2023040211, 2023040854, 2023041224; a) Model Number 24009, GTIN 20613994495420, Lot Numbers: 2023031043, 2023031563, 2023040211, 2023040480, 2023040854, 2023040855, 2023041224, 202305C108, 202305C109, 202306C196; b) Model Number 11316, GTIN 20613994676140, Lot Numbers: 2023040437; c) Model Number 11014L, GTIN 20613994495499, Lot Numbers: 2023040807, 2023040808, 202305C076, 202306C138
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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