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.
FDA Recall Z-1961-2009 · Posted 2009-09-03
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Recalling FirmB. Braun Interventional Systems
Recall StatusTerminated
Product CodeLJT
Date Initiated2009-06-22
Date Terminated2012-06-05
Product Quantity40 in US
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution -- NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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