Events

Recall of Device Recall HiZel, trayless, wound dressing, sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Embeem 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
    36831
  • Event Risk Class
    Class 2
  • Event Number
    Z-0455-2007
  • Event Initiated Date
    2006-11-09
  • Event Date Posted
    2007-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49426
  • 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
    Wound Dress - Product Code NAE
  • Reason
    Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material.
  • Action
    Recall letters were sent out on 11/9/2006 to the retail level

Device

Device Recall HiZel, trayless, wound dressing, sterile
  • Model / Serial
    There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.
  • Product Description
    HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.
  • Manufacturer
    Embeem Inc.

Manufacturer

Embeem Inc.
  • Manufacturer Address
    Embeem Inc., 18 Ireland Brook Dr, N Brunswick NJ 08902-4761
  • Source
    USFDA