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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Celsite Access Port		see related information
Date Posted September 03, 2009
Recall Number Z-1961-2009
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.
Code Information Lot Numbers: H3238310 and I0059950.
Recalling Firm/
Manufacturer		 B. Braun Interventional Systems
14276 23rd Ave N
Plymouth, Minnesota 55447-4910
Consumer Instructions No consumer action necessary
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
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.
 
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