3 lot numbers: "20100609", "20100610", and 20100611". Format is "YYYYMMXX" where YYYY is the year of manufacture, MM is the month, and XX is a sequential number identifying different lots manufactured in the same month.
Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
Description du dispositif
The product is the "FASTx Sternal Intraosseous Device". || The expiration date for the recalled products is end of June, 2012. || The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.