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U.S. Department of Health and Human Services

Class 2 Device Recall Celsite Implantable Access Port System

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  Class 2 Device Recall Celsite Implantable Access Port System see related information
Date Initiated by Firm June 16, 2015
Date Posted August 13, 2015
Recall Status1 Terminated 3 on November 20, 2015
Recall Number Z-2382-2015
Recall Event ID 71666
510(K)Number K130576  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
Code Information Lot number: 36896615
Recalling Firm/
Manufacturer		 B. Braun Interventional Systems
3050 Ranchview Ln N
Minneapolis MN 55447-1459
For Additional Information Contact Paul O'Connell
763-553-1006
Manufacturer Reason
for Recall		 The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action An Urgent Medical Device Recall letter, dated 6/16/2015 was sent to the 2 consignees via express mail. The letter explained the issue and requested the hospital review their inventory for the affected model and lot. If any quantities of the lot remained in inventory, the product was to be returned to BIS. A BIS sales representative will personally visit each account and complete an inventory sheet. Customers with questions can contact Paul O-Connell, President at 1-847-274-0097
Quantity in Commerce 11 units
Distribution CA and NY only.
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 = B. BRAUN INTERVENTIONAL SYSTEMS INC.
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