Reported Apr 8, 2015 · Terminated
Bio-MAC Cannula (Needle) Set
Biologic Therapies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biologic Therapies, Inc · 5817 Nw 44th Ave · Ocala, FL · 34482-7891
Is this the product you have?
- Bio-MAC Cannula (Needle) Set
- Lot codes and dates
- Catalog Numbers
Part # BMAC.25BMAC.45BMAC.60BMAC.80and BMAC.105
- Catalog Numbers
- Amount recalled
- 2797 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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