Bard Peripheral Vascular Inc: POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Is my product affected?

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

• UPC 00801741110726

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

What happened

Bard Peripheral Vascular Inc. is recalling 359 units of the POWERPORT ClearVUE Implantable Port with Smooth Septum due to incorrect port flushing instructions on the Patient ID Card packaged with the device. The affected units were distributed nationwide across multiple lot numbers produced between June 2017 and April 2019.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

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: 359 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0063 (01)00801741110726(17)170628(10)REAN0063 REAN1123 (01)00801741110726(17)170628(10)REAN1123 REAP0467 (01)00801741110726(17)170728(10)REAP0467 REAY1733 (01)00801741110726(17)180331(10)REAY1733 REBS1266 (01)00801741110726(17)180731(10)REBS1266 REBV1731 (01)00801741110726(17)181231(10)REBV1731 REBX1626 (01)00801741110726(17)190331(10)REBX1626 REBY0777 (01)00801741110726(17)190430(10)REBY0777

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.2018-02-08
• 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
• POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 16783002018-02-08

All FDA (Device enforcement) recalls