Bard POWERPORT ClearVUE Slim Implantable Port Recalled for Incorrect Instructions
Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included 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, and the source text identifies the issue as a labeling error (incorrect instructions) without reporting any injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 10 units of the POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005. 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 involves specific lot numbers identified by Unique Device Identifiers (UDIs) including REAN0056, REAN0203, REAP0773, and REBN0925.
Consumers and healthcare providers should check their inventory for these specific UDI codes. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 10
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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