Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
Reported: July 23, 2025 Initiated: June 5, 2025 #Z-2119-2025
Product Description
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
Reason for Recall
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Details
- Recalling Firm
- Waismed Ltd.
- Units Affected
- 516 units (US)
- Distribution
- Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy, Germany, Portugal, Spain, Ukraine, Lithuania, Chile, Poland, Germany, New Zealand, Montenegro, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan, Cyprus, and Israel.
- Location
- Herzliya, N/A
Frequently Asked Questions
What product was recalled? ▼
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A. Recalled by Waismed Ltd.. Units affected: 516 units (US).
Why was this product recalled? ▼
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2025. Severity: Moderate. Recall number: Z-2119-2025.
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