Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient Card Instructions
Bard Peripheral Vascular Inc is recalling 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, but the specific defect is a minor labeling error on the patient card with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 2,835 units of POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter (REF 1678300). 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 covers specific lots identified by Unique Device Identifiers (UDIs) including REAN0060, REAN1126, REAP0475, REAP0511, REAY0813, REAY0800, REBP1202, REBP1622, REBS1267, REBR1122, REBS1784, REBU1162, REBV1757, REBX1546, and REBY0830.
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, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 2,835
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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