medical Class II Updated 2018-05-16

Bard Peripheral Vascular Inc recalls POWERPORT ClearVUE isp Implantable Port With Smooth Septum a

Recalled Product

POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004

Hazard / Issue

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number Unique Device Identifier (UDI) REAN0057 (01)00801741110887(17)170628(10)REAN0057 REAN0204 (01)00801741110887(17)170628(10)REAN0204 REAP0770 (01)00801741110887(17)170728(10)REAP0770 REBP0837 (01)00801741110887(17)180131(10)REBP0837
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