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Terminated

ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

FDA Recall Z-1613-2015 · Posted 2015-05-14

Recalling FirmHandicare USA, Inc.
Recall StatusTerminated
Product CodeIKX
Date Initiated2015-03-26
Date Terminated2015-08-17
Product Quantity64

Reason for Recall

Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Distribution to the states of : FL, CA, NJ, NC and MD.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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