PowerPort ClearVUE recallZ-1769-2018 · Bard Peripheral Vascular Inc · initiated Feb 8, 2018

Why it was recalled

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

FDA root cause category: Error in labeling

What the company is doing

The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."

Recall details

Recall number

Z-1769-2018

Status

Completed

Initiated by the company

Feb 8, 2018

Recalling firm

Bard Peripheral Vascular Inc

Quantity

835 units

Product code

LJT

FDA submissions

K122899

Distribution

Nationwide

Product description

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• PowerPort ClearVUE 5676301

  Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall1 death12 reports

Product lines

• PowerPort ClearVUEBard Access Systems, Inc. · 27 models · 1,993 reports · 15 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 79841).

• Z-1760-2018 · Completed
  POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
• Z-1761-2018 · Completed
  POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
• Z-1762-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
• Z-1763-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
• Z-1764-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
• Z-1765-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
• Z-1766-2018 · Completed
  POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
• Z-1767-2018 · Completed
  POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
• Z-1768-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
• Z-1770-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
• Z-1771-2018 · Completed
  POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
• Z-1772-2018 · Completed
  POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
• Z-1773-2018 · Completed
  POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005