Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1964-2020·Announced 2020-05-20

Bard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size

Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the issue is a labeling/component mismatch (8Fr vs 6Fr lock) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving potential misuse or compatibility issues.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 200 units of the BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300. The recall is due to a labeling discrepancy where the catheter locks for the affected lot may contain an 8Fr catheter lock instead of the 6Fr catheter lock specified on the device labeling.

The affected product is identified by Lot #RECX3530 with an expiration date of 4/30/2020. The UDI is (01)00801741110771(17)200430(10)RECX3530. The product was distributed nationwide in the United States, including in Arizona, California, Massachusetts, Maryland, New Jersey, New York, and Texas. There was no foreign, government, or military distribution.

Healthcare facilities and consumers should check their inventory for this specific lot number and stop using the affected devices. They should contact Bard Peripheral Vascular Inc for further instructions on how to return or dispose of the product.

The recalled product

Product: 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…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Implantable Port
Hazard: mis-labeling
component-mismatch
Affected units: 200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot #RECX3530
Exp. date 4/30/2020
UDI (01)00801741110771(17)200430(10)RECX3530.

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Bard Peripheral Vascular Inc

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