Bio-MAC Cannula recall
Bio-MAC Cannula (Needle) Set
Why was Bio-MAC Cannula recalled?
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105
- Product
- Bio-MAC Cannula (Needle) Set
- Recalling firm
- Biologic Therapies, Inc
- Quantity
- 2797 units
- Distribution
- US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
- Recall date
- April 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)