FDAFDA · Food and drugs·Recall number Z-1764-2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Published May 16, 2018 · Recall initiated: February 8, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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