Bard Peripheral Vascular Inc recalls BardPort M.R.I. Hard Base Implantable Port with Attachable 9
Recalled Product
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 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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