Events

Recall of Device Recall Kendall

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kendall Healthcare Products Co.

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
    28090
  • Event Risk Class
    Class 2
  • Event Number
    Z-0382-04
  • Event Initiated Date
    2004-01-08
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31181
  • 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, Occlusive - Product Code NAD
  • Reason
    Sterility compromised due to lack of package seal integrity.
  • Action
    Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.

Device

Device Recall Kendall
  • Model / Serial
    Lot Number: 33452700
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
  • Product Description
    Kendall Curity Disposable Laparotomy Sponges, || 12 in x 12 in, Sterile || Product Number: 6034
  • Manufacturer
    Kendall Healthcare Products Co

Manufacturer

Kendall Healthcare Products Co
  • Manufacturer Address
    Kendall Healthcare Products Co, 15 Hampshire St, Mansfield MA 02048-1113
  • Source
    USFDA