Bio-MAC Cannula Set recalled over labeling errors
- Recall date
- January 23, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Biologic Therapies, Inc recalls Bio-MAC Cannula (Needle) Set
- Recall number
- Z-1373-2015
- FDA classification
- Class II
- Brand / firm
- Biologic Therapies, Inc
- Sold / distributed
- US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Why it was recalled
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bio-MAC Cannula (Needle) Set
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