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Recall Observatory FDA recall evidence

Device 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.

Z-2382-2015

June 16, 2015

Class II

Product summary

Firm
B. Braun Interventional Systems
Event
Event 71666
Status
Terminated
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2382-2015

Official wording

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

Code information: Lot number: 36896615

Distribution pattern: CA and NY only.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification