FDA Recall
Open, Classified
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Recall: Z-0838-2025
·
Initiated November 5, 2024
Recall
- Recall Number
- Z-0838-2025
- Event Number
- 95971
- Firm
- NOA Medical Industries Inc
- FEI Number
- 1000118429
- Product Code
- IKX
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- November 5, 2024
- Posted
- January 10, 2025
- Address
- 801 Terry Ln, Washington, MO, 63090-3543
Description
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Reason
Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
Action
NOA 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: [email protected] (email), https://www.noamedical.com/ (website) or 1-636-239-7600 (telephone), Monday-Friday 7:00AM to 3:30PM, CT.
Distribution
US: GA, MI. MA, CA
Quantity
34 units