The FDA has issued a Class I recall for Arstasis's One Access System recall device after reports that device components may separate during procedures. The device is used during femoral artery procedures for blood vessel access and to stop bleeding during the procedure.
Class I recalls are issued when a device's issue could cause serious injury or death to patients. A recall letter was sent to consumers Oct. 10, 2010, and it was posted on the FDA website Feb. 10.
- here's the Mass Device report