Bard Peripheral Vascular Inc: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300

Is my product affected?

BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use,

• UPC 00801741110771

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. is recalling 200 units of BARD Access Systems PowerPort ClearVUE Slim Implantable Port with Smooth Septum and Attachable 6F Polyurethane Open-Ended Single-Lumen Venous Catheter (Product #5676300) from Lot #RECX3530 with an expiration date of April 30, 2020. The catheter locks in this lot may contain an 8Fr catheter lock instead of the 6Fr catheter lock specified in the device labeling. The affected devices were distributed nationwide in the United States, including in Arizona, California, Massachusetts, Maryland, New Jersey, New York, and Texas.

The recall source does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

Details from the source

Reason for recall: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. Distribution: US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution. Quantity: 200 units Lot/code info: Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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