Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Celsite Implantable Access Port System Recalled by B. Braun Interventional Systems Due to The manufacturer, B. Braun medical France, received endotoxin...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact B. Braun Interventional Systems directly.
Affected Products
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.
Quantity: 11 units
Why Was This Recalled?
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Where Was This Sold?
This product was distributed to 2 states: CA, NY
About B. Braun Interventional Systems
B. Braun Interventional Systems has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report