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U.S. Department of Health and Human Services

Class 2 Device Recall SpineNet Bone Marrow Aspiration Needle Kit

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  Class 2 Device Recall SpineNet Bone Marrow Aspiration Needle Kit see related information
Date Initiated by Firm February 04, 2013
Date Posted August 27, 2013
Recall Status1 Terminated 3 on November 15, 2013
Recall Number Z-2107-2013
Recall Event ID 65914
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M).

Use to aspirate bone morrow.
Code Information Lot # 22754F16 and #25854I17
Recalling Firm/
Manufacturer		 SpineNet
1300 Minnesota Ave
Suite 200
Winter Park FL 32789-4800
For Additional Information Contact Brenda Cabrera
407-539-2483
Manufacturer Reason
for Recall		 SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
FDA Determined
Cause 2		 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 in Commerce 100 units
Distribution Distributed to one customer in Florida.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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