B. Braun Interventional Systems recalls Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems)…

Recall date

June 16, 2015

Source

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

Recall number

Z-2382-2015

FDA classification

Class II

Brand / firm

B. Braun Interventional Systems

Sold / distributed

CA and NY only.

Why it was recalled

The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

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

What was recalled

Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.