• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Celsite Access Port

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Celsite Access Port
see related information
Date Posted September 03, 2009
Recall Status1 Open
Recall Number Z-1961-2009
Recall Event ID 52611
Premarket Notification
510(K) Numbers
K061424  K952548 
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, Minnesota 55447-4910
Consumer Instructions No consumer action necessary
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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.
-
-