The Recall Desk
ModerateFDA (Devices)·Z-1760-2018·Announced 2018-05-16

Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Instructions

Bard Peripheral Vascular Inc is recalling 359 units of POWERPORT ClearVUE implantable ports because the included patient ID card contains incorrect flushing instructions.

What this means for you

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 involves a labeling error (incorrect instructions) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 359 units of the POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter (REF 1666362). The recall is due to incorrect port flushing instructions printed on the Patient ID Card packaged with the device.

The affected units were distributed nationwide. The recall is classified as Class II by the FDA. The source text does not specify the number of reported injuries or illnesses associated with this recall.

Healthcare providers and patients should verify the lot numbers and expiration dates of their devices against the recall list. If a device is affected, users should contact Bard Peripheral Vascular Inc for further instructions regarding the correct flushing procedures.

The recalled product

Product
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Affected units
359

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →