FDA recall Z-1238-2022

Oakworks Inc · Class II · device

Product

PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

Reason for recall

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.

Distribution

US Nationwide distribution in the states of MA, NJ, and PA.

Key facts

Status
Terminated
Initiation date
2022-04-21
Report date
2022-06-15
Termination date
2024-09-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Freedom, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1238-2022