Events

Recall of Device Recall Sterilux

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hartmann USA, 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
    61899
  • Event Risk Class
    Class 2
  • Event Number
    Z-1858-2012
  • Event Initiated Date
    2012-05-14
  • Event Date Posted
    2012-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109342
  • 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,nonresorbable for external use - Product Code NAB
  • Reason
    Micro holes were detected in the laminate of the sterile barrier system of sterilized hartmann econolux and hartmann sterilux gauze products.
  • Action
    The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.

Device

Device Recall Sterilux
  • Model / Serial
    Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.
  • Product Description
    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges || For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
  • Manufacturer
    Hartmann USA, Inc

Manufacturer

Hartmann USA, Inc
  • Manufacturer Address
    Hartmann USA, Inc, 481 Lakeshore Pkwy, Rock Hill SC 29730-4205
  • Manufacturer Parent Company (2017)
    Schwenk Limes Gmbh & Co. Kg
  • Source
    USFDA