Filters In Intravenous Filter Sets
The IV sets are intended
to be a sterile pathway for the administration of a variety of intravenous
fluids. They are used on newborns and on adult and pediatric patients
whose immune system is compromised.
One of the incidence of
recall by FDA indicated that the filters in the IV sets may contain a 1.2
micron filter instead of a 0.22 micron filter. If a 1.2 micron filter is
used as a 0.22 micron, the filter will fail to function as intended and
could result in the infusion of particles leading to a blockage of small
vessels and/or infusion of bacteria creating a potential for infection.
FDA considers that the
probability of life threatening consequences is likely to occur by use of
these devices until the correction is made.
More details at :
About The Center for Devices and Radiological Health (CDRH)
MEDICAL DEVICES AND RADIATION-EMITTING ELECTRONIC PRODUCTS : INTERNATIONAL ACTIVITIES
Within FDA, the Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices; to promote quality in mammographic services; and to control unnecessary human exposure to potentially hazardous radiation and ensure the safe, efficacious use of such radiation. The Center reviews and evaluates medical device pre-market approval (PMA) applications, exemption requests for investigational devices (IDEs), and pre-market notifications [510(k)s]. CDRH also develops and enforces performance standards for medical devices and radiation-emitting electronic products and GMP regulations.
Under the Safe Medical Devices Act of 1990, CDRH has established an International Staff to coordinate the development of agreements with foreign countries in order to facilitate trade in devices. Additional information about medical device international activities is available on its International Program page.