FDA-Device2015-07-29Class II

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

Argon Medical Devices, Inc
Hazard

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

Sold states
US
Affected count
6390 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2188-2015

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