FDAClass IIApril 8, 2015

Bio-PLASTY Cannula recall

Bio-PLASTY Cannula (Needle)

Why was Bio-PLASTY 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 # BPC.45, BPC.60, BPC.80, and BPC.105

Product
Bio-PLASTY Cannula (Needle)
Recalling firm
Biologic Therapies, Inc
Quantity
58
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)
Open FDA enforcement record Latest recalls