FDA-Device2015-04-08Class II
Bio-MAC Cannula (Needle) Set
Biologic Therapies, Inc
Hazard
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Sold states
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Affected count
2797 units
Manufactured in
5817 Nw 44th Ave, N/A, Ocala, FL, United States
Products
Bio-MAC Cannula (Needle) Set
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1373-2015Don't want to check this manually?
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