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FDA (Device enforcement)Recalled 2018-02-08class ii

Bard Peripheral Vascular Inc: POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

Is my product affected?

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

  • UPC 00801741110764

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

What happened

Bard Peripheral Vascular Inc. has recalled 1,551 units of POWERPORT ClearVUE Slim with Smooth Septum implantable ports distributed nationwide. The recall was initiated because the Patient ID Card included with the device contains incorrect instructions for flushing the port.

The source does not specify what action affected consumers should take 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: 1551 units Lot/code info: Lot Number Unique Device Identifier (UDI) REAN0062 (01)00801741110764(17)170628(10)REAN0062 REAP0628 (01)00801741110764(17)170828(10)REAP0628 REAU0228 (01)00801741110764(17)171228(10)REAU0228 REAW1710 (01)00801741110764(17)180331(10)REAW1710 REAY0677 (01)00801741110764(17)180531(10)REAY0677 REAY2493 (01)00801741110764(17)180331(10)REAY2493 REBQ0468 (01)00801741110764(17)180331(10)REBQ0468 REBS1274 (01)00801741110764(17)180930(10)REBS1274 REBS1900 (01)00801741110764(17)180930(10)REBS1900 REBT2147 (01)00801741110764(17)181130(10)REBT2147 REBV1310 (01)00801741110764(17)181231(10)REBV1310 REBW0863 (01)00801741110764(17)181231(10)REBW0863 REBX2269 (01)00801741110764(17)190430(10)REBX2269

Source

Official record: FDA (Device enforcement) ↗

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

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