Recall Z-1613-2015
Handicare USA, Inc. · initiated March 26, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Codes / lots: All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
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 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.
Details
- Recall number
- Z-1613-2015
- Initiated
- March 26, 2015
- Posted by FDA
- May 14, 2015
- Terminated
- August 17, 2015
- Product code
- IKX – Aid, Transfer
- Quantity
- 64
- Distribution
- US Distribution to the states of : FL, CA, NJ, NC and MD.
- Recalling firm
- Handicare USA, Inc., Allentown, PA