FDA Device recall Z-1761-2018
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
- FDA Device
- Class II
- completed
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362 by Bard Peripheral Vascular, citing the Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1761-2018 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-02-08 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Reason
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Identifiers
| code_info | Lot Number Unique Device Identifier (UDI) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)008017411107…Lot Number Unique Device Identifier (UDI) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1761-2018%22
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