Events

Recall of Device Recall Hydrofilm

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
    58136
  • Event Risk Class
    Class 3
  • Event Number
    Z-1866-2011
  • Event Initiated Date
    2011-02-11
  • Event Date Posted
    2011-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98447
  • 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 and burn, occlusive - Product Code MGP
  • Reason
    Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. consignees were notified by letter on/about 02/11/2011. they were advised to examine their inventory and not to use any of the affected product and to return it to paul hartmann. a response form was included to be completed and returned to paul hartmann. they were further instructed to pass the no.
  • Action
    Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

Device

Device Recall Hydrofilm
  • Model / Serial
    Lot number: 000543118
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.
  • Product Description
    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany
  • 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