Bard POWERPORT ClearVUE Slim Catheter Recalled for Incorrect Patient ID Card Instructions
Bard Peripheral Vascular Inc is recalling 383 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 on a card) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 383 units of POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes (REF 1678301). 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 specific lot numbers and Unique Device Identifiers (UDIs) for the recalled units are REAN0067, REAP0630, REAS2309, REAV2088, REAY0330, REBS1275, REBT1568, and REBV0713.
Healthcare providers and patients should check their inventory or patient records for these specific lot numbers. If the device is in use, they should contact Bard Peripheral Vascular Inc for further instructions regarding the replacement of the Patient ID Card or the device itself.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 383
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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