Z-1613-2015Class II

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

Name: Z-1613-2015 ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid
Creator: Handicare USA, Inc.
Published: 2015-03-26
License: https://open.fda.gov/license/

Handicare USA, Inc. / initiated 2015-03-26 / Terminated / root cause: design

FDA source

Handicare USA, Inc. began a recall of ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid on 2015-03-26. FDA classified it as Class II and gives the reason as "Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1613-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-05-14
Terminated: 2015-08-17
Recalling firm: Handicare USA, Inc.
Product: ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Product code: IKX Aid, Transfer
Reason for recall: Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
Root cause tag: design
FDA root 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.
Product codes and lots: All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1613-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-14

Product code IKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)