Stanley Bed-Check 30-Day IT Bed Sensormat, With 8 Ft. Cord, Model 74010, 10 mats per inner box, 5 inner boxes per overpa

FDA device recall Z-1860-2011 · posted 2011-03-31 · Terminated

Recall details

Recalling firm

Stanley Security Solutions, Inc.

Reason for recall

The cord could come loose from the mat potentially causing a short to the internal wiring.

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

KMI

Quantity affected

29,574 mats

Distribution

Worldwide distribution: USA and the country of Canada.

Date initiated

2009-11-25

Date posted

2011-03-31

Date terminated

2011-03-31

Location

Lincoln, NE