FDA Device recall Z-1764-2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
- FDA Device
- Class II
- completed
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300 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-1764-2018 |
| 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 Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
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) REAN0060 (01)00801741110801(17)170628(10)REAN0060 REAN1126 (01)008017411108…Lot Number Unique Device Identifier (UDI) REAN0060 (01)00801741110801(17)170628(10)REAN0060 REAN1126 (01)00801741110801(17)170628(10)REAN1126 REAP0475 (01)00801741110801(17)170728(10)REAP0475 REAP0511 (01)00801741110801(17)170728(10)REAP0511 REAY0813 (01)00801741110801(17)171031(10)REAY0813 REAY0800 (01)00801741110801(17)171031(10)REAY0800 REBP1202 (01)00801741110801(17)180131(10)REBP1202 REBP1622 (01)00801741110801(17)180131(10)REBP1622 REBS1267 (01)00801741110801(17)180731(10)REBS1267 REBR1122 (01)00801741110801(17)180930(10)REBR1122 REBS1784 (01)00801741110801(17)180930(10)REBS1784 REBU1162 (01)00801741110801(17)181130(10)REBU1162 REBV1757 (01)00801741110801(17)190228(10)REBV1757 REBX1546 (01)00801741110801(17)190331(10)REBX1546 REBY0830 (01)00801741110801(17)190430(10)REBY0830 |
|---|
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-1764-2018%22
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