FDA Device recall Z-2382-2015

Celsite Implantable Access Port System, model ST301

FDA Device
Class II
terminated
Published 2015-08-19

On 2015-08-19 the FDA classified a Class II recall of Celsite Implantable Access Port System, model ST301 by B Braun Interventional Systems, citing the manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2382-2015
Classification	Class II
Status	terminated
Initiated	2015-06-16
Published	2015-08-19
Last updated	2026-09-13 11:53 UTC
Company	B Braun Interventional Systems
Distribution	CA, NY

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.

Reason

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

Identifiers

code_info	Lot number: 36896615

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2382-2015%22

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