CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
Titanium Single Lumen Low-Profile port recalled by Bard Access Systems
Bard Access Systems is recalling Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone Catheter, distributed nationwide in the US. The recall was initiated on 6 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0815-2014
- FDA event ID
- 66991
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 6 Dec 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +48 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
Where it was distributed
Worldwide Distribution - US nationwide, Belgium, and Canada.
Questions about this recall
Is Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone Catheter recalled?
Yes. Bard Access Systems recalled Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone Catheter on 6 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0815-2014.
Why was it recalled?
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.
Which lots are affected?
Lot REXC0467
Where was it sold?
Worldwide Distribution - US nationwide, Belgium, and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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