Device product
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Z-1765-2018
Product summary
- Event
- Event 79841
- Status
- Completed
- Classification
- Class II
- Quantity
- 383 units
- Official record key
device-enforcement:Z-1765-2018
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) REAN0067 (01)00801741110825(17)170628(10)REAN0067 REAP0630 (01)00801741110825(17)170728(10)REAP0630 REAS2309 (01)00801741110825(17)171028(10)REAS2309 REAV2088 (01)00801741110825(17)171028(10)REAV2088 REAY0330 (01)00801741110825(17)171031(10)REAY0330 REBS1275 (01)00801741110825(17)180731(10)REBS1275 REBT1568 (01)00801741110825(17)181031(10)REBT1568 REBV0713 (01)00801741110825(17)181231(10)REBV0713
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.