Bard POWERPORT ClearVUE Implantable Port Recall for Incorrect Instructions
Bard Peripheral Vascular Inc is recalling 15 units of POWERPORT ClearVUE isp 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 involves a minor labeling error (incorrect instructions) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or labeling issues.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 15 units of the POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004. 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 specific units involved are identified by the following Unique Device Identifiers (UDIs): REAN0057, REAN0204, REAP0770, and REBP0837.
Consumers and healthcare providers should check their inventory for these specific UDI codes. If the recalled product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by Bard Peripheral Vascular Inc.
The recalled product
- Product
- POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 15
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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