Z-2382-2015 Class II Terminated
FDA device recall Z-2382-2015 was initiated by B. Braun Interventional Systems on June 16, 2015 and is designated Class II. Reason for recall: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537). The recall status is terminated (terminated November 20, 2015). Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2015
- Initiation Date
- June 16, 2015
- Termination Date
- November 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
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.
Reason for Recall
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Distribution Pattern
CA and NY only.
Code Information
Lot number: 36896615