FDAClass IISeptember 4, 2013

SpineNet Bone Marrow Aspiration Needle Kit recall

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

Why was SpineNet Bone Marrow Aspiration Needle Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 22754F16 and #25854I17

Product
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Recalling firm
SpineNet
Quantity
100 units
Distribution
Distributed to one customer in Florida.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls