Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters 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 and involves a minor labeling error (incorrect instructions) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes (REF 1676301). 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 includes specific lots identified by UDI codes REAN0065, REAP0473, REAX1813, REAZ0278, REBS1438, and REBT1881.
Healthcare providers and patients should verify the lot numbers of their devices against the recall list. If a device is affected, users should contact Bard Peripheral Vascular Inc for further instructions regarding the incorrect flushing guidelines.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 216
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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