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Terminated

PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

FDA Recall Z-1238-2022 · Posted None

Recalling FirmOakworks Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated2022-04-21
Date Terminated2024-09-19
Product Quantity130

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.

Firm 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 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.

Root Cause

Error in labeling

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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