Z-1961-2009

Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product...

Name: Z-1961-2009 Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product...
Creator: B. Braun Interventional Systems
Published: 2009-06-22
License: https://open.fda.gov/license/

B. BRAUN INTERVENTIONAL SYSTEMS Inc. / initiated 2009-06-22 / Terminated / root cause: manufacturing process

FDA source

B. Braun Interventional Systems began a recall of Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems on 2009-06-22. The reason FDA records is "B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1961-2009
Status: Terminated
Initiated: 2009-06-22
Posted: 2009-09-03
Terminated: 2012-06-05
Recalling firm: B. BRAUN INTERVENTIONAL SYSTEMS Inc.
Product: Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: B. Braun Interventional Systems, Inc. issued an "Urgent: Medical Device Recall" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted. For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.
Quantity in commerce: 40 in US
Distribution: Nationwide Distribution -- NY.
Product codes and lots: Lot Numbers: H3238310 and I0059950.

Product code LJT

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)