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
|