FDAFDA · Food and drugs·Recall number Z-0818-2019
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Published February 13, 2019 · Recall initiated: December 18, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiotech (Manan Medical Products, Inc.)
- Distributor
- Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
- Lot
- Model Number UCIN-16-5, Lot Number LK2L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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