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.
FDA Recall Z-2382-2015 · Posted 2015-08-13
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Recalling FirmB. Braun Interventional Systems
Recall StatusTerminated
Product CodeLJT
Date Initiated2015-06-16
Date Terminated2015-11-20
Product Quantity11 units
Reason for Recall
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
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
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
CA and NY only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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