Recall Z-2107-2013 ยท GAA Needle, Aspiration And Injection, Disposable
SpineNet
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
| Date | Aug 27, 2013 (initiated Feb 4, 2013) |
| Status | Terminated |
| Reason | SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 100 units |
| Distribution | Distributed to one customer in Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.