Medical device recalls Moderate risk

R82 A/S recalls Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 9532…

Recall date
March 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1315-2019
FDA classification
Class II
Brand / firm
R82 A/S
Sold / distributed
US in the states of NC

Why it was recalled

Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)

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