Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions
Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.
What this means for you
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 could lead to improper use of a medical device. While no injuries are reported, the risk of harm from incorrect flushing instructions for an implantable port justifies a High severity rating.
Plain-English summary
Bard Peripheral Vascular Inc is voluntarily recalling the POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes (REF 5678300). The recall affects 1,411 units distributed nationwide. The issue stems from the Patient ID Card packaged with the implantable port containing incorrect instructions for flushing the port.
The affected products are identified by specific Lot Numbers and their corresponding Unique Device Identifiers (UDI). Affected lots include REAN0061, REAP0772, REAT1524, REAV1479, REAV1938, REAW0937, REAW1186, REAW1666, REAY0528, REAY0795, REAZ1529, REBN0024, REBN1581, REBQ0210, REBS1277, REBR1125, REBS1395, REBS2412, REBT1785, REBT2349, REBU0563, REBV0760, and REBW1037.
Healthcare providers and patients should check the lot numbers on their devices against the list above. If a device is part of this recall, users should refer to the correct flushing instructions provided by the manufacturer or contact Bard Peripheral Vascular Inc for further guidance.
The recalled product
- Product
- POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 1,411
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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