Events

Recall of Device Recall BioCORE Cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biologic Therapies, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70445
  • Event Risk Class
    Class 2
  • Event Number
    Z-1374-2015
  • Event Initiated Date
    2015-01-23
  • Event Date Posted
    2015-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133874
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cannula, injection - Product Code FGY
  • Reason
    Devices are misbranded - failure to properly classify and obtain fda clearance prior distribution.
  • Action
    On January 23, 2015 the firm sent an URGENT: Class II MEDICAL DEVICE RECALL notification asking its consignees to: 1) Quarantine all remaining devices in their inventory and return the product to Biologic Therapies Inc. via UPS Ground. Product returns should be shipped under UPS Account #A197E9 and must reference RMA#15-0115-01. Please ship to the Biologic Therapies Inc. address listed at the bottom of Page 5. To coordinate return shipping, please contact Biologic Therapies, Inc. via the contact information provided.Contact hours: Monday - Friday 8am to 5pm Eastern Standard Time. (352) 304-5149 2) Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Device

Device Recall BioCORE Cannula
  • Model / Serial
    Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
  • Product Description
    Bio-CORE Cannula (Needle) Set
  • Manufacturer
    Biologic Therapies, Inc

Manufacturer

Biologic Therapies, Inc
  • Manufacturer Address
    Biologic Therapies, Inc, 5817 Nw 44th Ave, Ocala FL 34482-7891
  • Manufacturer Parent Company (2017)
    Biologic Therapies, Inc
  • Source
    USFDA