FDA recall Z-1687-2021

James Leckey Design Ltd · Class II · device

Product

MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.

Reason for recall

Due to a failure of the welds, the casters detached from the rear legs of the walker.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of CA and WI and the countries of Italy, Norway, Australia, Czechia, Netherlands, Denmark, New Zealand, Japan, United Arab Emirates, Qatar, Croatia, Spain, Poland, Russia, South Africa, Taiwan, Saudi Arabia, Chemitec, Centre Harika, Hong Kong, Lebanon, Belgium, Philippines, Singapore, Malaysia, Indonesia, Slovakia, China, and France.

Key facts

Status
Ongoing
Initiation date
2021-03-01
Report date
2021-06-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lisburn, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1687-2021