Waismed Ltd.: 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 intraoss

Hazard

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

Details from the source

Reason for recall: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. 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, Croati Quantity: 516 units (US) Lot/code info: Lot Code: UDI: 07290008325073 Lot number: 2440044

UPC codes

07290008325073

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.