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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Recall Number Z-2107-2013
Classification Class II
Code Info Lot # 22754F16 and #25854I17
Product Distributed Qty 100 units
Reason For Recall SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

Event Detail

Event Id 65914
Product Type Devices
Status Ongoing
Recalling Firm SpineNet
City Winter Park
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed to one customer in Florida.