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B. Braun Interventional Systems recalls Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems)
Recalled August 19, 2015 · FDA recall Z-2382-2015 · B. Braun Interventional Systems
Hazard
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537). · FDA Class II
Units
11 units
Sold at
CA and NY only.
Description
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
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.
Manufacturer(s)
B. Braun Interventional Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →