Z-1768-2018 Class II
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- February 8, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3196 units
Product Description
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Reason for Recall
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Distribution Pattern
Nationwide
Code Information
Lot Number Unique Device Identifier (UDI) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052