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Terminated

SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.

FDA Recall Z-2107-2013 · Posted 2013-08-27

Recalling FirmSpineNet
Recall StatusTerminated
Product CodeGAA
Date Initiated2013-02-04
Date Terminated2013-11-15
Product Quantity100 units

Reason for Recall

SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

Distributed to one customer in Florida.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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