The Recall Desk
ModerateFDA (Devices)·Z-1766-2018·Announced 2018-05-16

Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Flushing Instructions

Bard Peripheral Vascular Inc is recalling 876 units of POWERPORT ClearVUE Implantable Ports because the packaged Patient ID Card contains incorrect port 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a labeling error regarding flushing instructions, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 876 units of the POWERPORT ClearVUE Implantable Port with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter (REF 5666362). The recall is due to a labeling error where the Patient ID Card packaged with the device contains incorrect port flushing instructions.

The affected products were distributed nationwide. The recall covers specific lots identified by Unique Device Identifiers (UDIs) including REAN0067, REAP0630, REAS2309, REAV2088, REAY0330, REBS1275, REBT1568, and REBV0713.

Healthcare providers and patients should verify the lot numbers of their devices against the list provided by the manufacturer. 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 ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Affected units
876

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 →