Recall Z-1763-2018— Bard Peripheral Vascular Inc

Name: FDA recall Z-1763-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-08

Class II · Completed

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2018-02-08. It names one FDA 510(k) clearance: K122899. Product: POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301. Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Completed
Initiated: 2018-02-08
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K122899 — POWERPORT CLEARVUE SLIM IMPLANTABLE PORTC.R. Bard, Inc.·cleared 2012-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.