Recall Z-1238-2022 ยท FNL Bed, Ac-Powered Adjustable Hospital
Oakworks Inc
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
| Date | Apr 21, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | On April 21, 2022, the firm notified customers via mail and email of the field action. Customers should identify and locate all affected products. Distributors should quarantine the product and notify any customers who have received the product. For users, the product remains functional and can continue to be used. All customers should complete the included response form and return to Oakworks. Oakworks will set up a service visit to replace the labels on the affected beds. If you have any questions or concerns, please contact Oakworks Customer Service Department at 800-558-8850 or 717-235- |
| Quantity | 130 |
| Distribution | US Nationwide distribution in the states of MA, NJ, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.