Bard Peripheral Vascular Inc recalls 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ende
Recalled Product
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Without Suture Plugs, (01)00801741026737; 3. PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 1759600 Air Guard, With Suture Plugs, (01)00801741026850 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Hazard / Issue
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Issued by
FDA
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