TGA Reference Number: RC-2020-RN-00251-1 March 2020

Attention: Users, customers, carers, parents, therapists, and health professional staff.

Products affected: ALL LECKEY MYWAY HARNESSES

The affected products were manufactured and distributed in Australia after January 2019.

Product Code	Size	Colour
173-4100-04	1	Purple
173-4200-07	2	Green
173-4300-02	3	Blue
173-4400-09	4	Red
173-4500-06	5	Orange
173-4600-08	6	Grey

Description of the problem:

The manufacturer Leckey, has advised Sunrise Medical and your distributor that through their post-market surveillance activities, they have observed a very small number of isolated complaints relating to a reduction in the adhesiveness of the Velcro on the MyWay harnesses.  The MyWay harness consists of two Velcro locking mechanisms.  All reported failures relate to the first Velcro strap (refer Picture A).

Leckey have had no recorded incidents where the secondary Velcro strap has failed (refer Picture B). To date, there have been no injuries reported in relation to this issue.

As explained in the user instructions, please ensure that the first Velcro strap (Picture A) is holding firmly before commencing with the use of the product. If either of the Velcro straps is damaged, badly worn or ineffective, then do not use the product.

Solution to problem:

Leckey have introduced a new design that has added two additional buckles to the harness as well as increasing the effectiveness of the existing Velcro (higher cycle life; refer Picture C). The revised design has been rigorously tested and proven to be efficacious and safe.

Action to be taken by the user:

• You have been contacted as our records indicate that you have an affected MyWay harness. If this is incorrect and you have disposed of, sold or otherwise transferred the ownership of your harness can you please complete and return the attached form.

• If you do not return the form then Sunrise Medical via your distributor will supply you a new harness free of charge when stocks of the new design are available. This is expected to be before the end of May 2020.

• and never use a badly worn harness.  In particular, carefully check:
  • the harness and all straps/buckles for signs of wear and tear
  • the Velcro strip and remove any fluff caught in the Velcro hooks to ensure it secures firmly
  • the harness hoisting point and hoisting straps for signs of wear and tear.

• Once you receive the replacement harness, it is essential that you return the old harness to your distributor in the supplied return addressed envelope. It is a requirement that all old units are returned for secure destruction.

Important!

If in any doubt, please contact your distributor or Sunrise Medical Australia’s customer service centre on (02) 9678 6600.

We sincerely apologise for any inconvenience caused by this medical device recall.

Please contact us if you have a MyWay walker supplied from Active Rehab, and we will make sure you receive a new harness