Device product

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

Z-1769-2018

February 08, 2018

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 79841
Status: Completed
Classification: Class II
Quantity: 835 units
Official record key: device-enforcement:Z-1769-2018

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) REAN0066 (01)00801741110795(17)170528(10)REAN0066 REAP0629 (01)00801741110795(17)170728(10)REAP0629 REAY1483 (01)00801741110795(17)180531(10)REAY1483 REAY2494 (01)00801741110795(17)180331(10)REAY2494 REBS0163 (01)00801741110795(17)181031(10)REBS0163 REBT0364 (01)00801741110795(17)181130(10)REBT0364 REBT1664 (01)00801741110795(17)181231(10)REBT1664 REBT2149 (01)00801741110795(17)181231(10)REBT2149 REBW0874 (01)00801741110795(17)190331(10)REBW0874 REBY1231 (01)00801741110795(17)190430(10)REBY1231

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.