Medical device recalls Moderate risk

Argon Medical Devices, Inc recalls Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part N…

Recall date
June 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2188-2015
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

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 Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601

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