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