Events

Recall of Device Recall V. Mueller Peanut Sponges

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by He, 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
    56420
  • Event Risk Class
    Class 2
  • Event Number
    Z-2296-2010
  • Event Initiated Date
    2010-03-01
  • Event Date Posted
    2010-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93622
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDI
  • Reason
    Sterile product packaging contains weak seals, which may result in compromised product sterility.
  • Action
    Harod Enterprises, Inc. (HE) issued a "Notice of Recall" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product. Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165.

Device

Device Recall V. Mueller Peanut Sponges
  • Model / Serial
    Product Code: 23275-470, Lot number 3405
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: including state of IL.
  • Product Description
    V. Mueller¿ Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.
  • Manufacturer
    He, Inc

Manufacturer

He, Inc
  • Manufacturer Address
    He, Inc, 4052 Indian Creek Rd, Martinez GA 30907-2234
  • Source
    USFDA