Device product

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

Z-1760-2018

February 08, 2018

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 79841
Status: Completed
Classification: Class II
Quantity: 359 units
Official record key: device-enforcement:Z-1760-2018

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) 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

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.