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.
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, 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
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- 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.
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