FDAFDA · Food and drugs·Recall number Z-1374-2015
Bio-CORE Cannula (Needle) Set
Published April 8, 2015 · Recall initiated: January 23, 2015
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
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biologic Therapies, Inc
- Distributor
- US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
- Lot
- Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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