FDAClass IIJuly 29, 2015

T-Lok Bone Marrow Biopsy Needle recall: Sterility Concern

T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL…

Why was T-Lok Bone Marrow Biopsy 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: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173

Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL…
Recalling firm
Argon Medical Devices, Inc
Quantity
10290 units
Distribution
US
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls