www.fdanews.com/articles/134159-arstasis-recalls-one-access-system-over-fracture-issues
Arstasis Recalls One Access System Over Fracture Issues
February 10, 2011
Arstasis is recalling certain lots of its One Access System, a catheterization device designed for procedures in the femoral artery. The recall comes after the company discovered some components could fracture during use. The FDA has classified the recall as Class I.