Medical Components, Inc dba MedComp recalls 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection po…

Recall date

January 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1527-2015

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.

Why it was recalled

The dual port with catheters was not covered under FDA clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.