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.
This recall has been terminated (originally issued September 3, 2009).
- Company
- B. Braun Interventional Systems
- Recall Initiated
- June 22, 2009
- Posted
- September 3, 2009
- Terminated
- June 5, 2012
- Recall Number
- Z-1961-2009
- Quantity
- 40 in US
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution -- NY.
Lot / Code Info
Lot Numbers: H3238310 and I0059950.
Root Cause
Nonconforming Material/Component
Action Taken
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.