Events

Recall of Device Recall Adiprep Adipose Transfer System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo BCT, 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
    75589
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-2017
  • Event Initiated Date
    2016-11-03
  • Event Date Posted
    2016-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150857
  • 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
    System, suction, lipoplasty - Product Code MUU
  • Reason
    Terumo bct announces a voluntary field action for the harvest : adiprep adipose transfer system because the affected product is incorrectly labeled and has the potential for operator confusion.
  • Action
    Consignees will be notified on 11/07/16 via letter to contact the North America Terumo BCT support center at +1.877.842.7837 or +1.303.542.5050 if they have any affected product to issue a Return Goods Authorization for product return.

Device

Device Recall Adiprep Adipose Transfer System
  • Model / Serial
    Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
  • Product Description
    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
  • Manufacturer
    Terumo BCT, Inc.

Manufacturer

Terumo BCT, Inc.
  • Manufacturer Address
    Terumo BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA