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-1373-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief