Device product
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
Z-1763-2018
Product summary
- Event
- Event 79841
- Status
- Completed
- Classification
- Class II
- Quantity
- 216 units
- Official record key
device-enforcement:Z-1763-2018
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) REAN0065 (01)00801741110788(17)170628(10)REAN0065 REAP0473 (01)00801741110788(17)170728(10)REAP0473 REAX1813 (01)00801741110788(17)180430(10)REAX1813 REAZ0278 (01)00801741110788(17)180331(10)REAZ0278 REBS1438 (01)00801741110788(17)180930(10)REBS1438 REBT1881 (01)00801741110788(17)180930(10)REBT1881
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.