Medical device recalls Moderate risk

Oakworks Inc recalls PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

Recall date
April 21, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1238-2022
FDA classification
Class II
Brand / firm
Oakworks Inc
Sold / distributed
US Nationwide distribution in the states of MA, NJ, and PA.

Why it was recalled

Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

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

What was recalled

PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

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