The Recall Desk
ModerateFDA (Devices)·Z-1768-2018·Announced 2018-05-16

Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Flushing Instructions

Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim catheters because the included 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 and involves a labeling error (incorrect instructions) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheters (REF 5676300). The recall is due to a labeling error where the Patient ID Card packaged with the device contains incorrect port flushing instructions.

The affected units were distributed nationwide. The recall covers specific lots identified by Unique Device Identifiers (UDIs) ranging from REAN0055 to REBX2052, with expiration dates spanning from May 2017 to April 2019.

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 on how to proceed with the recall and to obtain correct flushing instructions.

The recalled product

Product
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Affected units
3,196

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 →