Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions
Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
What this means for you
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 on a patient card) 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 835 units of POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes (REF 5676301). 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 covers specific lots identified by UDI codes REAN0066, REAP0629, REAY1483, REAY2494, REBS0163, REBT0364, REBT1664, REBT2149, REBW0874, and REBY1231.
Healthcare providers and patients should verify the lot numbers of their devices against the list provided by the manufacturer. If the device is affected, users should contact Bard Peripheral Vascular Inc for further instructions regarding the correct flushing procedures.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 835
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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