Z-0910-2013Class II

Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous...

Name: Z-0910-2013 Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous...
Creator: Bard Access Systems
Published: 2013-02-21
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2013-02-21 / Terminated

FDA source

Bard Access Systems began a recall of Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product... on 2013-02-21. FDA classified it as Class II and gives the reason as "Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0910-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-21
Posted: 2013-03-06
Terminated: 2014-01-03
Recalling firm: Bard Access Systems, Inc.
Product: Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.
Product code: DYB Introducer, Catheter
Reason for recall: Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
FDA root cause: Mixed-up of materials/components
Action: Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.
Quantity in commerce: 73 units
Distribution: USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
Product codes and lots: Lot numbers: HUWI1379 and HUWI1380.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0910-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0909-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-05
Z-0910-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-05

Product code DYB

K830233Class IINon-Sterile,single/souble Lumen-CathEvermed, Inc. / cleared 1983-02-28

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)