Recall Z-2382-2015 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
B. Braun Interventional Systems
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, whic
| Date | Aug 13, 2015 (initiated Jun 16, 2015) |
| Status | Terminated |
| Reason | The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537). |
| Root cause | 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 | 11 units |
| Distribution | CA and NY only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS B. Braun Interventional Systems, Inc., Apr 2, 2013 |