Class 2 Device Recall Stanley BedCheck 90Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001

• Date Initiated by Firm: November 25, 2009
• Date Posted: March 31, 2011
• Recall Status: Terminated on March 31, 2011
• Recall Number: Z-1856-2011
• Recall Event ID: 57987
• Product Classification: Monitor, bed patient - Product Code KMI
• Product: Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per inner box, 5 inner boxes per overpack box (total 25 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.
• Code Information: Lot numbers A1009, A0809, A0609, A0409, and A0309.
• Recalling Firm/ Manufacturer: Stanley Security Solutions, Inc.; 1550 N 20th Cir; Lincoln NE 68503-1101
• For Additional Information Contact: Gina L. Bennett; 407-206-5127
• Manufacturer Reason for Recall: The cord could come loose from the mat potentially causing a short to the internal wiring.
• FDA Determined Cause: Process change control
• 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.
• Quantity in Commerce: 4,195 mats
• Distribution: Worldwide distribution: USA and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.