Recall Z-2382-2015— B. Braun Interventional Systems

Name: FDA recall Z-2382-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-16

Class II · Terminated

Class II FDA medical device recall by B. Braun Interventional Systems, initiated 2015-06-16, terminated 2015-11-20. It names one FDA 510(k) clearance: K130576. Product: 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.. Reason: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537)..

Recalling firm: B. Braun Interventional Systems
Classification: Class II
Status: Terminated
Initiated: 2015-06-16
Terminated: 2015-11-20
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K130576 — CELSITE IMPLANTABLE ACCESS PORT SYSTEMSB. Braun Interventional Systems, Inc.·cleared 2013-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.