Medical device recalls Moderate risk

Argon Medical Devices, Inc recalls T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Ca…

Recall date
June 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2189-2015
FDA classification
Class II
Brand / firm
Argon Medical Devices, Inc
Sold / distributed
US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

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