Waismed Ltd.: 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-o

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: 7056 units (US) Lot/code info: UDI: 0 7290008325059 Lot number: 2440043, 2440045, 2540046, 2540047

UPC codes

7290008325059

Source

Official record: FDA (Device enforcement) ↗

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