Events

Recall of Device Recall Barrier Hip Sheet with Side Pockets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Molnlycke Health Care 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
    26694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1137-03
  • Event Initiated Date
    2003-07-14
  • Event Date Posted
    2003-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28181
  • 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
    Drape, Surgical - Product Code KKX
  • Reason
    Pouch may tear which could result in contamination of sterile field.
  • Action
    The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.

Device

Device Recall Barrier Hip Sheet with Side Pockets
  • Model / Serial
    Product Code 0202 Lot numbers 03149759 and 03165584. Product Code 0204 Lot numbers 030305, 030321, and 03165583. Product Code 9202 Lot numbers 250203, 03205562, and 03255432.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.
  • Product Description
    Barrier Hip Sheet with Side Pockets
  • Manufacturer
    Molnlycke Health Care Inc

Manufacturer

Molnlycke Health Care Inc
  • Manufacturer Address
    Molnlycke Health Care Inc, 826 Newtown-Yardley Road, Newton, Pa PA 18940
  • Source
    USFDA