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U.S. Department of Health and Human Services

Class 2 Device Recall NOA Medical Industries behavioral health bed side rails

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 Class 2 Device Recall NOA Medical Industries behavioral health bed side railssee related information
Date Initiated by FirmNovember 05, 2024
Date PostedJanuary 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0838-2025
Recall Event ID 95971
Product Classification Aid, transfer - Product Code IKX
ProductNOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Code Information UDI/DI 00817492012745, Serial Numbers: 2038043534, 2038042756, 2038042755, 2038042750, 2038042751, 2038042752, 2038042753, 2038042754, 2038042757, 2038042244, 2038041722, 2038038738, 2038038750, 2038038749, 2038038748, 2038038747, 2038038746, 2038038745, 2038038744, 2038038758, 2038038757, 2038038756, 2038038754, 2038038753, 2038038752, 2038038755, 2038038743, 2038038742, 2038038737, 2038038751, 2038038739, 2038038740, 2038038741, 2038038766.
FEI Number 1000118429
Recalling Firm/
Manufacturer		 NOA Medical Industries Inc
801 Terry Ln
Washington MO 63090-3543
For Additional Information ContactKaren Coke
636-231-6031
Manufacturer Reason
for Recall		Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
FDA Determined
Cause 2		Device Design
ActionNOA Medical Industries issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 11/05/2024 via email. The notice explained the problem with the device, potential risk, and temporary actions to employ to minimize the hazard until a replacement frame is installed. A replacement side rail will be provided. For questions or concerns, contact: support@noamedical.com (email), https://www.noamedical.com/ (website) or 1-636-239-7600 (telephone), Monday-Friday 7:00AM to 3:30PM, CT.
Quantity in Commerce34 units
DistributionUS: GA, MI. MA, CA
Total Product Life CycleTPLC 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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