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

FDA device recall Z-1613-2015 · posted 2015-05-14 · Terminated

Recall details

Recalling firm

Handicare USA, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

IKX

Quantity affected

64

Distribution

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

Date initiated

2015-03-26

Date posted

2015-05-14

Date terminated

2015-08-17

Location

Allentown, PA