Reported Aug 19, 2015 · Terminated
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems)…
B. Braun Interventional Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Interventional Systems · 3050 Ranchview Ln N · Minneapolis, MN · 55447-1459
Is this the product you have?
- 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.
- Lot codes and dates
- Lot number36896615
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
This product could cause temporary or reversible health problems — stop using it.
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