FDAFDA · Food and drugs·Recall number Z-1766-2018
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
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) REAN0067 (01)00801741110825(17)170628(10)REAN0067 REAP0630 (01)00801741110825(17)170728(10)REAP0630 REAS2309 (01)00801741110825(17)171028(10)REAS2309 REAV2088 (01)00801741110825(17)171028(10)REAV2088 REAY0330 (01)00801741110825(17)171031(10)REAY0330 REBS1275 (01)00801741110825(17)180731(10)REBS1275 REBT1568 (01)00801741110825(17)181031(10)REBT1568 REBV0713 (01)00801741110825(17)181231(10)REBV0713
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.