Events

Recall of Device Recall Purefill Oxygen Compressor, model PF1100

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inovo, 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
    75312
  • Event Risk Class
    Class 2
  • Event Number
    Z-0760-2017
  • Event Initiated Date
    2016-07-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150020
  • 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
    Generator, oxygen, portable - Product Code CAW
  • Reason
    Device can fail during operation.
  • Action
    The firm, Inovo, Inc, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated Sept 2, 2016 to all their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and isolate the devices in their inventory and return them to Inovo Inc. Also, if the consignee sold or distributed the device, the consignee needs to retrieve and return the units to Inovo Inc. as soon as possible and complete and return the Medical Device Return Response form in the self-addressed stamped envelope provided or email to: regulatory@inovoin.com or fax to Inovo, Inc. Any questions please contact at 814-443-7602 or via e-mail at regulatory@inovoinc.com.

Device

Device Recall Purefill Oxygen Compressor, model PF1100
  • Model / Serial
    Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to states of: AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA.
  • Product Description
    INOVO Purefill Oxygen Compressor Model PF1100 || Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
  • Manufacturer
    Inovo, Inc

Manufacturer

Inovo, Inc
  • Manufacturer Address
    Inovo, Inc, 401 Leonard Blvd N, Lehigh Acres FL 33971-6302
  • Manufacturer Parent Company (2017)
    Medical Depot Inc.
  • Source
    USFDA