Device product

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

Z-1762-2018

February 08, 2018

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 79841
Status: Completed
Classification: Class II
Quantity: 1551 units
Official record key: device-enforcement:Z-1762-2018

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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