B. Braun Interventional Systems: Medical Device Recall in 2015 - (Recall #: Z-2382-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 16, 2015

Date Posted: August 19, 2015

Recall Number: Z-2382-2015

Event ID: 71666

Reason for Recall:

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

Status: Terminated

Product Quantity: 11 units

Code Information:

Lot number: 36896615

Distribution Pattern:

CA and NY only.

Voluntary or Mandated:

Voluntary: Firm initiated