FDAOctober 1, 2019device

BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infu...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

UPCs

00801741025563

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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