FDA Medical Device Recalls (openFDA)
B. Braun Interventional Systems: 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.
- Recall number
- Z-1961-2009
- Recalling firm
- B. Braun Interventional Systems
- 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.
- Status
- Terminated
- Initiated
- 2009-06-22
- Posted
- 2009-09-03
- Terminated
- 2012-06-05
- Reason
- 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
- 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
- 40 in US
- Distribution
- Nationwide Distribution -- NY.
- Lot, serial or model codes
- Lot Numbers: H3238310 and I0059950.
- 510(k) numbers
- ["K061424","K952548"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3006332832
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28