Events

Recall of Device Recall Stanley BedCheck 30Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanley Security Solutions, 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
    57987
  • Event Risk Class
    Class 2
  • Event Number
    Z-1860-2011
  • Event Initiated Date
    2009-11-25
  • Event Date Posted
    2011-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97933
  • 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
    Monitor, bed patient - Product Code KMI
  • Reason
    The cord could come loose from the mat potentially causing a short to the internal wiring.
  • Action
    The firm, Stanley Healthcare Solutions, issued an "Important Technical Bulletin" dated November 25, 2009 to all customers via e-mail. In addition, the firm issued a "Compliance Notice" dated August 30, 2010 via certified mail because the firm had not collected all of the units with the defect. The bulletin described the product, problem and actions to be taken. The customers were instructed to check the cords on the mats to make sure they weren't pulled out, if the cords were pulled out, they were to return the mats for replacement; contact Customer Service at 1-800-824-2996 ext: 3440 to obtain a return authorization number and take immediate action to return the units to the firms location in Lincoln, Nebraska. The Compliance Notice informed the customers who had not sent in their units to promptly read the notice and take the necessary steps to respond appropriately for their facility. Additionally, the customers were instructed to complete and return the Bed Check Sensormat Return Form and page 2 of the "Compliance Notice" via at 402-475-4281 or mail to: Compliance Engineer, Stanley Security Solutions, Inc., 1550 N. 20th Circle, Lincoln, NE 68503. Follow-up phone calls to nonresponders were made using a phone script. A "Second Notice Compliance Notice" dated October 20, 2010 was issued via certified mail to customers asking for immediate response to the previous communication. In addition, a third notice dated October 28, 2010 which was also flagged as "Second Notice" was again used asking for a response from the customers. If you have any questions regarding the notice or any action that may need to be taken by you, please contact Quality Manager at 1-800-824-2996 extension 3419 or Compliance Officers at 402-742-9414 or 402-742-9425.

Device

Device Recall Stanley BedCheck 30Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010
  • Model / Serial
    Lot numbers A1009, B1009, A0809, B0809, A0609, B0609, A0409, and B0409.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and the country of Canada.
  • Product Description
    Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per inner box, 5 inner boxes per overpack box (total 50 units). The firm name on the box is Stanley, 1-800-523-7956. The mat contains only the phone number. || For use in reducing patient falls.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Manufacturer Address
    Stanley Security Solutions, Inc., 1550 N 20th Cir, Lincoln NE 68503-1101
  • Manufacturer Parent Company (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA