SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspira
FDA device recall Z-2107-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- SpineNet
- Reason for recall
- SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
- Action taken
- SpineNET sent a "VOLUNTARY PRODUCT RECALL" letter dated 02/04/2013 to Halifax Medical Center. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 407-539-2483 for questions regarding this notice.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- GAA
- Quantity affected
- 100 units
- Distribution
- Distributed to one customer in Florida.
- Date initiated
- 2013-02-04
- Date posted
- 2013-08-27
- Date terminated
- 2013-11-15
- Location
- Winter Park, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.