Events

Recall of Device Recall Biogel Skinsense

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
    39362
  • Event Risk Class
    Class 2
  • Event Number
    Z-1219-2007
  • Event Initiated Date
    2007-07-20
  • Event Date Posted
    2007-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55283
  • 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
  • Reason
    Sterility compromised (package integrity): the primary packaging for a portion of the lot may contain gloves that were not sealed properly.
  • Action
    Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.

Device

Device Recall Biogel Skinsense
  • Model / Serial
    Lot #07B026, Size 8
  • Distribution
    Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI
  • Product Description
    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia
  • Manufacturer
    Molnlycke Health Care, Inc

Manufacturer

Molnlycke Health Care, Inc
  • Manufacturer Address
    Molnlycke Health Care, Inc, 5550 Peachtree Pkwy Ste 500, Norcross GA 30092-2555
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    USFDA