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U.S. Department of Health and Human Services

Class 2 Device Recall Celsite Access Port

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  Class 2 Device Recall Celsite Access Port see related information
Date Initiated by Firm June 22, 2009
Date Posted September 03, 2009
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1961-2009
Recall Event ID 52611
510(K)Number K952548  K061424  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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 MN 55447-4910
For Additional Information Contact
763-553-1006
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = AESCULAP, INC.
510(K)s with Product Code = LJT and Original Applicant = B. BRAUN MEDICAL, INC.
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