Recall Z-1964-2020— Bard Peripheral Vascular Inc

Name: FDA recall Z-1964-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-15

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2020-01-15. It names one FDA 510(k) clearance: K122899. Product: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.. Reason: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-01-15
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

BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

Reason for recall

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

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