Recall Z-1238-2022— Oakworks Inc
Class II · Terminated
Class II FDA medical device recall by Oakworks Inc, initiated 2022-04-21, terminated 2024-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19. Reason: 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..
- Recalling firm
- Oakworks Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-21
- Terminated
- 2024-09-19
- Firm location
- New Freedom, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.