Food, drugs, devices › Bard Access Systems

Device recall: MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6

FDA enforcement event 66991 · Class II · initiated 6 Dec 2013 · status Terminated · terminated 5 Aug 2014

DeviceVoluntary: Firm initiated2 product recordsSalt Lake City, UT

Bard Access Systems (Salt Lake City, UT) initiated this device recall on 6 Dec 2013; FDA lists 2 product records under event 66991, classified Class II.

FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 5 Aug 2014. Initiation: voluntary: firm initiated. Bard Access Systems has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Bard Access Systems, Salt Lake City, UT.

Reason for recall

"Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device."

Distribution

"Worldwide Distribution - US nationwide, Belgium, and Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0814-2014	MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used…	1358	Class II	Terminated	29 Jan 2014
Z-0815-2014	Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These…	200	Class II	Terminated	29 Jan 2014

Context

90%of 2013 device events are Class II1,236 events that year

2product records in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for 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 therm	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
10 Jun 2013	StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ devi	Device	Class II	1

All 13 events for Bard Access Systems

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US nationwide, Belgium, and Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.