FDAFDA · Food and drugs·Recall number Z-2107-2013
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Published September 4, 2013 · Recall initiated: February 4, 2013
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
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineNet
- Distributor
- Distributed to one customer in Florida.
- Lot
- Lot # 22754F16 and #25854I17
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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