NIO-A intraosseous device stabilizer may not release properly after insertion
The NIO-A NIO Intraosseous Device Adult is being recalled because a manufacturing error means the built-in stabilizer may not be released properly after deployment and insertion. 7,056 US units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: an in-use mechanical failure on an emergency vascular access device, with no injury reported in the source.
Plain-English summary
The NIO-A NIO Intraosseous Device Adult, catalog number 105000603, UDI 07290008325059, is being recalled. NIO devices are spring-based, automatic intraosseous access devices supplied sterile. The action covers 7,056 units in the United States, from lots 2440043, 2440045, 2540046 and 2540047.
The stated reason is that, due to a manufacturing error, the intraosseous device built-in stabilizer may not be released properly after deployment and insertion. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including in North Carolina in the United States. The devices are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access t
- Manufacturer
- Waismed Ltd.
- Hazard
- manufacturing-error
- stabilizer-release
- intraosseous-access
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 0 7290008325059 Lot number: 2440043
- 2440045
- 2540046
- 2540047
Distribution
Distributed nationwide across the United States.
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