Z-2382-2015Class II

Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite...

Name: Z-2382-2015 Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite...
Creator: B. Braun Interventional Systems
Published: 2015-06-16
License: https://open.fda.gov/license/

B. BRAUN INTERVENTIONAL SYSTEMS Inc. / initiated 2015-06-16 / Terminated / root cause: sterility

FDA source

B. Braun Interventional Systems began a recall of Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter... on 2015-06-16. FDA classified it as Class II and gives the reason as "The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2382-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-16
Posted: 2015-08-13
Terminated: 2015-11-20
Recalling firm: B. BRAUN INTERVENTIONAL SYSTEMS Inc.
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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: An Urgent Medical Device Recall letter, dated 6/16/2015 was sent to the 2 consignees via express mail. The letter explained the issue and requested the hospital review their inventory for the affected model and lot. If any quantities of the lot remained in inventory, the product was to be returned to BIS. A BIS sales representative will personally visit each account and complete an inventory sheet. Customers with questions can contact Paul O-Connell, President at 1-847-274-0097
Quantity in commerce: 11 units
Distribution: CA and NY only.
Product codes and lots: Lot number: 36896615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2382-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2382-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13

Product code LJT

K130576Class IICelsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. / cleared 2013-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)