FDA-Device2017-02-22Class II

BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens

Argon Medical Devices, Inc
Hazard

The recalling firm received a complaint from one of their customers of a 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
Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Affected count
497 boxes
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1194-2017

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