FDA-Device2019-02-13Class II

"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Angiotech (Manan Medical Products, Inc.)
Hazard

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Sold states
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Affected count
9,900 units
Manufactured in
241 W Palatine Rd, Wheeling, IL, United States
Products
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2019

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