Events

Recall of Device Recall The Fig Leaf Drain Bag

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

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
    68456
  • Event Risk Class
    Class 2
  • Event Number
    Z-1848-2014
  • Event Initiated Date
    2011-01-11
  • Event Date Posted
    2014-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127728
  • 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
    Urinary drainage collection kit, for indwelling catheter - Product Code FCN
  • Reason
    Sterigear notifed customers of circumstances in which the fig leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
  • Action
    SteriGear, LLC sent a special note to all affected customers between January 12, 2011 and September 28, 2012. The note identified the product, the problem, and the action to be taken by the customer. Customers were instructed on how to reposition the inlet tube. Customers with questions were instructed to contact Director of Product Development at 801-607-3211. No correction or removal was performed. For questions regarding this recall call 801-607-3209.

Device

Device Recall The Fig Leaf Drain Bag
  • Model / Serial
    UPD 851616002007, Part 10270
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO || Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
  • Manufacturer
    SteriGear, LLC

Manufacturer

SteriGear, LLC
  • Manufacturer Address
    SteriGear, LLC, 362 S University Ave, Provo UT 84601-4472
  • Manufacturer Parent Company (2017)
    SteriGear LLC
  • Source
    USFDA