The Recall Desk
ModerateFDA (Devices)·Z-1761-2018·Announced 2018-05-16

Bard POWERPORT ClearVUE isp Catheter Recalled for Incorrect Instructions

Bard Peripheral Vascular Inc is recalling 2,395 units of POWERPORT ClearVUE isp catheters 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, and the hazard is a minor labeling error (incorrect instructions) without reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 2,395 units of the POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter (REF 1668362). 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 includes specific lot numbers and Unique Device Identifiers (UDIs) such as REAN0058, REAN0205, REAN1124, REAP0769, REAT1312, REBP1357, REBR0999, and REBV0758.

Healthcare providers and patients should verify the lot numbers of their devices against the recall list. If a device is affected, users should follow the instructions provided by the recalling firm or their healthcare provider regarding the correct port flushing procedures.

The recalled product

Product
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Affected units
2,395

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 →