Class 2 Device Recall Re Turn

• Date Initiated by Firm: March 26, 2015
• Date Posted: May 14, 2015
• Recall Status: Terminated on August 17, 2015
• Recall Number: Z-1613-2015
• Recall Event ID: 70995
• Product Classification: Aid, transfer - Product Code IKX
• Product: ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
• Code Information: All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
• Recalling Firm/ Manufacturer: Handicare USA, Inc.; 2201 Hangar Pl; Ste 200; Allentown PA 18109-9342
• For Additional Information Contact: Customer Support; 717-733-1444
• Manufacturer Reason for Recall: Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
• FDA Determined Cause: Device Design
• Action: Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information (required by FDA). Thank you for your support. We are committed to re-releasing the wipeable ReTurn belt as soon as we believe that it meets the quality standards that you expect from Handicare. Please contact our Customer Experience team at 1-866-276-5438 if you have any questions regarding the recall or would like assistance with the recall. We regret any inconvenience that this action may cause, but we appreciate your understanding as we take action to ensure patient and customer satisfaction.
• Quantity in Commerce: 64
• Distribution: US Distribution to the states of : FL, CA, NJ, NC and MD.
• 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.