Recall of Device Recall Medical Maggots with the accessory LeFlap dressing

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Monarch Labs, 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
    56031
  • Event Risk Class
    Class 2
  • Event Number
    Z-2207-2010
  • Event Initiated Date
    2009-05-03
  • Event Date Posted
    2010-08-11
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-12-13
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Medical Maggots - Product Code NQK
  • Reason
    Monarch labs initiated the field notification regarding their medical maggots from batch mm090406 with the accessory leflap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.
  • Action
    The customer recall communication was initiated on May 3, 2009 with Monarch Labs notifying all consignees with a via a faxed Recall Letter with fax-back attachment of the initial compliant they had received and the possible infection that may occur if instructions for use are not followed. All therapists, who used maggots from that batch were instructed to contact the firm immediately if they have experienced any adverse events, such as infection, cellulitis, or any other problem. If not, they were asked to simply return the fax-back attachment , noting "no problem" .

Device

  • Model / Serial
    Batch #: MM-090406 with CCII-0901
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.
  • Product Description
    Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. || Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Monarch Labs, LLC, 17875 Sky Park Circle, Ste K, Irvine CA 92614
  • Manufacturer Parent Company (2017)
  • Source
    USFDA