Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions
Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II due to incorrect instructions that pose a risk of harm where injury has not yet been reported. Incorrect flushing instructions for an implantable port can lead to device malfunction or infection, constituting a significant risk of harm.
Plain-English summary
Bard Peripheral Vascular Inc is voluntarily recalling the POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter (REF 1676300). The recall affects 1551 units distributed nationwide. The specific issue involves the Patient ID Card packaged with the implantable port, which contains incorrect instructions for flushing the port.
The affected products are identified by lot numbers and Unique Device Identifiers (UDI) including REAN0062, REAP0628, REAU0228, REAW1710, REAY0677, REAY2493, REBQ0468, REBS1274, REBS1900, REBT2147, REBV1310, REBW0863, and REBX2269. These units were distributed across the United States.
Consumers who possess this product should check their Patient ID Card for the incorrect flushing instructions and contact Bard Peripheral Vascular Inc for further guidance on how to proceed.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 1,551
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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