Class 1 Device Recall Vail 2000 Enclosed Bed System.

• Date Initiated by Firm: May 06, 2005
• Date Posted: June 30, 2005
• Recall Status: Terminated on January 05, 2011
• Recall Number: Z-0863-05
• Recall Event ID: 32055
• 510(K)Number: K963622
• Product Classification: Bed, Ac-Powered Adjustable Hospital - Product Code FNL
• Product: Vail 2000 Enclosed Bed System.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Vail Products Inc; 235 1st St; Toledo OH 43605-2041
• For Additional Information Contact: Robyn Shinaver; 419-698-3200
• Manufacturer Reason for Recall: Risk of patient entrapment, may result in serious injury or death.
• FDA Determined Cause: Device Design
• Action: The recalling firm sent consignees an urgent notification letter, dated 5/6/05.
• Quantity in Commerce: 1004 beds in distribution.
• Distribution: Nationwide, Puerto Rico, Canada and Saudi Arabia. MA, RI, NH, ME, VT, CT, NJ, NY, PA, DE, Washington DC, VA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, and AK.
• 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.

• 510(K) Database: 510(K)s with Product Code = FNL and Original Applicant = VAIL PRODUCTS, INC.