Bard Peripheral Vascular Inc: POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

Is my product affected?

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

• UPC 00801741110788

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

What happened

Bard Peripheral Vascular Inc. is recalling 216 units of the POWERPORT ClearVUE Slim Implantable Port with Smooth Septum because the Patient ID Card packaged with the device contains incorrect port flushing instructions. The affected devices were distributed nationwide across six lot numbers with expiration dates ranging from June 2017 to September 2018.

The recall notice does not specify a remedy or instructions for what affected consumers should do.

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: 216 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0065 (01)00801741110788(17)170628(10)REAN0065 REAP0473 (01)00801741110788(17)170728(10)REAP0473 REAX1813 (01)00801741110788(17)180430(10)REAX1813 REAZ0278 (01)00801741110788(17)180331(10)REAZ0278 REBS1438 (01)00801741110788(17)180930(10)REBS1438 REBT1881 (01)00801741110788(17)180930(10)REBT1881

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(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 16663622018-02-08
• 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, 8F ChronoFlex, Polyurethane Catheter, REF 16783002018-02-08

All FDA (Device enforcement) recalls