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

Is my product affected?

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

• UPC 00801741110887

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. is recalling 15 units of the POWERPORT ClearVUE Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit distributed nationwide. The Patient ID Card packaged with the device contains incorrect port flushing instructions.

The affected lot numbers are REAN0057, REAN0204, REAP0770, and REBP0837. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. Distribution: Nationwide Quantity: 15 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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• POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 16683622018-02-08
• POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 16763002018-02-08
• POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 16763012018-02-08

All FDA (Device enforcement) recalls