Events

Recall of Device Recall Lipogems, Aspiration Cannulae

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

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
    72904
  • Event Risk Class
    Class 2
  • Event Number
    Z-0690-2016
  • Event Initiated Date
    2015-12-15
  • Event Date Posted
    2016-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142457
  • 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
    The cannulae may bend during procedure.
  • Action
    Consignees were notified by telephone and letter via FedEx on/about 12/15/2015.

Device

Device Recall Lipogems, Aspiration Cannulae
  • Model / Serial
    Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, CT, FL, GA, NJ and NY.
  • Product Description
    Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
  • Manufacturer
    Globalmed Logistix

Manufacturer

Globalmed Logistix
  • Manufacturer Address
    Globalmed Logistix, 1880 Beaver Ridge Cir Ste D, Norcross GA 30071-3833
  • Manufacturer Parent Company (2017)
    Globalmed Logistix Llc
  • Source
    USFDA