Device recall: Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer…

Class II FDA enforcement event 64425. Recall start date: 21 Feb 2013. Status in the FDA record: Terminated. Termination date: 3 Jan 2014.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Bard Access Systems started this device recall on 21 Feb 2013. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class II. FDA event 64425 has 2 product records. The first FDA enforcement report date is 13 Mar 2013. The record gives the status Terminated, with the termination date 3 Jan 2014.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.

Recalling firm

Bard Access Systems, Salt Lake City, UT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 64425: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0909-2013	Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate…	195 units.	Class II	Terminated	13 Mar 2013
Z-0910-2013	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.	73 units	Class II	Terminated	13 Mar 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 13

Other events of the firm

Other FDA enforcement events of Bard Access Systems
Initiated	Product (first record)	Type	Class	Records
19 Dec 2016	MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermo	Device	Class II	2
9 Dec 2016	StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad	Device	Class II	2
20 Jul 2015	Marketing brochures for the PowerPICC and PowerPICC SOLO catheters	Device	Class II	1
27 May 2015	PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo cat	Device	Class III	4
13 Mar 2015	PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended fo	Device	Class II	1
3 Nov 2014	GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Cod	Device	Class II	1
8 Aug 2014	BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lu	Device	Class II	5
24 Jun 2014	Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.	Device	Class II	1
27 Feb 2014	PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Produ	Device	Class II	1
6 Dec 2013	MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6	Device	Class II	2

Bard Access Systems: all 13 events

Official channels

FDA enforcement report Z-0909-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 64425. https://recallregister.com/fda/ii/64425/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
What quantity of product is in FDA event 64425?: The event has 2 product records. The first record gives this quantity: 195 units.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.