Events

Recall of Device Recall Manuka Honey Wound Gel

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

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
    79765
  • Event Risk Class
    Class 2
  • Event Number
    Z-1630-2018
  • Event Initiated Date
    2018-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163294
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    Incorrect gel part number listed in a master manufacturing record.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. .

Device

Device Recall Manuka Honey Wound Gel
  • Model / Serial
    Lot# 1610; 1621; 1639; 1737; 1745
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    US state of RI
  • Product Description
    Manuka Honey Wound Gel || Catalogue No: 716597 || Product Usage: || Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.