Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters
Bard Peripheral Vascular Inc is recalling 4,044 POWERPORT ClearVUE catheters because the 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. The hazard involves incorrect instructions on a patient information card rather than a direct physical defect in the device itself or reported injuries. This aligns with moderate severity for precautionary recalls involving documentation errors without reported harm.
Plain-English summary
Bard Peripheral Vascular Inc has issued a recall for the POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter (REF 5668362). The company is recalling 4,044 units distributed nationwide. The affected products include specific lot numbers identified by their Unique Device Identifiers: REAN0059, REAN1125, REAP0627, REBN2011, REBP0853, REBS1276, REBS2291, REBU1357, REBW1455, and REBY0778.
The reason for the recall is that the Patient ID Card packaged with the implantable port contains incorrect instructions for flushing the port. This error could potentially lead to improper maintenance of the device by patients or healthcare providers.
Consumers who possess this specific catheter should check their Patient ID Card against the recalled lot numbers and contact Bard Peripheral Vascular Inc for further guidance on how to proceed.
The recalled product
- Product
- POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 4,044
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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