FDAClass IIJuly 29, 2015

Bone Marrow Aspiration Needle recall: Sterility Concern

Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow…

Why was Bone Marrow Aspiration Needle recalled?

Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

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 Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707

Product
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow…
Recalling firm
Argon Medical Devices, Inc
Quantity
6390 units
Distribution
US
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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