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U.S. Department of Health and Human Services

Class 2 Device Recall PX200 Emergency Relief Bed

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  Class 2 Device Recall PX200 Emergency Relief Bed see related information
Date Initiated by Firm April 21, 2022
Create Date June 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1238-2022
Recall Event ID 90172
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Code Information UDI-DI: 00817463026399 Serial Numbers: PXR769629 PXR769630 PXR769631 PXR769632 PXR769633 PXR769634 PXR769635 PXR769636 PXR769637 PXR769638 PXR769639 PXR769640 PXR769641 PXR769642 PXR769643 PXR769644 PXR769645 PXR769646 PXR769647 PXR769648 PXR769649 PXR769650 PXR769651 PXR769652 PXR769653 PXR769654 PXR769655 PXR769656 PXR769657 PXR769658 PXR769730 PXR769731 PXR769732 PXR769733 PXR769734 PXR769735 PXR769736 PXR769737 PXR769738 PXR769739 PXR769740 PXR769741 PXR769742 PXR769743 PXR769744 PXR769745 PXR769746 PXR769747 PXR769748 PXR769749 PXR769750 PXR769751 PXR769752 PXR769753 PXR769754 PXR769755 PXR769756 PXR769757 PXR769758 PXR769759 PXR769760 PXR769761 PXR769762 PXR769763 PXR769764 PXR769765 PXR769766 PXR769767 PXR769768 PXR769769 PXR769770 PXR769771 PXR769772 PXR769773 PXR769774 PXR769775 PXR769776 PXR769777 PXR769778 PXR769779 PXR769780 PXR769781 PXR769782 PXR769783 PXR769784 PXR769785 PXR769786 PXR769787 PXR769788 PXR769789 PXR769790 PXR769791 PXR769792 PXR769793 PXR769794 PXR769795 PXR769796 PXR769797 PXR769798 PXR769799 PXR769800 PXR769801 PXR769802 PXR769803 PXR769804 PXR769805 PXR769806 PXR769807 PXR769808 PXR769809 PXR769810 PXR769811 PXR769812 PXR769813 PXR769814 PXR769815 PXR769816 PXR769817 PXR769818 PXR769819 PXR769820 PXR769821 PXR769822 PXR769823 PXR769824 PXR769825 PXR769826 PXR769827 PXR769828 PXR769829
Recalling Firm/
Manufacturer		 Oakworks Inc
923 E Wellspring Rd
New Freedom PA 17349-8408
For Additional Information Contact Stephen McKinley
717-235-6807
Manufacturer 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.
FDA Determined
Cause 2		 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 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
Quantity in Commerce 130
Distribution US Nationwide distribution in the states of MA, NJ, and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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