Class 2 Device Recall Alimed Gait Belt (Transfer Aid)

• Date Initiated by Firm: October 30, 2008
• Date Posted: January 22, 2009
• Recall Status: Terminated on September 09, 2011
• Recall Number: Z-0598-2009
• Recall Event ID: 50127
• Product Classification: Transfer Aid - Product Code IKX
• Product: Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108
• Code Information: Lot Numbers: Y8739, Y8296, Y7619, Y7004, Y5966 and Y3169.
• Recalling Firm/ Manufacturer: AliMed Corporation; 297 High St; Dedham MA 02026
• For Additional Information Contact: SAME; 781-329-2900 Ext. 126
• Manufacturer Reason for Recall: Misassembled gait (transfer aid) belt.
• FDA Determined Cause: Employee error
• Action: Alimed notified accounts via U.S. Postal Service (Return Receipt Requested) with a Recall Notice dated 10/30/2008 and instructs users to review their records and notify all users to whom the product may have been issued. If any of the product has been issued outside of their facility, customers are to forward the correspondence to them in it's entirety. Customers are to complete the enclosed form for return of their product (new or used) and the issuance of replacement product or credit.
• Quantity in Commerce: 993 units total
• Distribution: Nationwide Distribution
• 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.