Recall Z-2107-2013
SpineNet · initiated February 4, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Codes / lots: Lot # 22754F16 and #25854I17
Reason for recall
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
FDA-determined cause: No Marketing Application
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.
Details
- Recall number
- Z-2107-2013
- Initiated
- February 4, 2013
- Posted by FDA
- August 27, 2013
- Terminated
- November 15, 2013
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 100 units
- Distribution
- Distributed to one customer in Florida.
- Recalling firm
- SpineNet, Winter Park, FL