Device product
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
Z-1769-2018
Product summary
- 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
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.