Bard Peripheral Vascular Inc: POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

Is my product affected?

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

• UPC 00801741110771

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

What happened

Bard Peripheral Vascular Inc. is recalling 3,196 units of the POWERPORT ClearVUE Slim with Smooth Septum implantable port nationwide. The Patient ID Card included with the device contains incorrect instructions for flushing the port. The recall affects multiple lot numbers distributed between June 2017 and April 2019.

The recall notice does not specify a remedy or recommended action for consumers who have received this device.

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: 3196 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052

Source

Official record: FDA (Device enforcement) ↗

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

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• 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, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 16763012018-02-08

All FDA (Device enforcement) recalls