FDA recall record

James Leckey Design MyWay Walker Chassis - Product Usage: is intended for use by children recall — FDA Z-1687-2021

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

Class IIclassification
Z-1687-2021official record ID
Jun 2, 2021report date

Recall record at a glance

Official recordZ-1687-2021
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmJames Leckey Design Ltd
Report dateJun 2, 2021
Recall initiation dateMar 1, 2021
Quantity2,719 walkers
LocationLisburn, N/A, United Kingdom

Official product description

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

Why the product was recalled

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

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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