Class 2 Device Recall ParaSlyde, Controlled descent device.

• Date Initiated by Firm: October 29, 2008
• Date Posted: December 28, 2009
• Recall Status: Terminated on January 28, 2010
• Recall Number: Z-0568-2010
• Recall Event ID: 53339
• Product Classification: Stretcher, hand-carried - Product Code FPP
• Product: Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
• Code Information: Lot number 08/219/B.
• FEI Number: 3004828791
• Recalling Firm/ Manufacturer: Paramed Systems; 8100 S 1300 W Ste D; West Jordan UT 84088-8307
• For Additional Information Contact: 801-304-9299
• Manufacturer Reason for Recall: Possible partial board disassembly due to inadequate webbing attachment.
• FDA Determined Cause: Process change control
• Action: Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices.
• Quantity in Commerce: 722 Units
• Distribution: Nationwide Distribution -- Including states of AZ, CA, FL, GA, IL, IN, KS, KY, MA, MI, MT, NY, PA, SC, TN and UT.
• 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.