Z-1964-2020Class II

BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F...

Name: Z-1964-2020 BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F...
Creator: Bard Peripheral Vascular Inc
Published: 2020-01-15
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2020-01-15 / Open, Classified / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter... on 2020-01-15. FDA classified it as Class II and gives the reason as "The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1964-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-01-15
Posted: 2020-05-12
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
Quantity in commerce: 200 units
Distribution: US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Product codes and lots: Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1964-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-20	2020-05-12

Product code LJT

K122899Class IIPowerport Clearvue Slim Implantable PortC.R. Bard, Inc. / cleared 2012-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)