Bard Access Systems: Medical Device Recall in 2014 - (Recall #: Z-0814-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 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.

Product Classification:

Class II

Date Initiated: December 6, 2013

Date Posted: January 29, 2014

Recall Number: Z-0814-2014

Event ID: 66991

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.

Status: Terminated

Product Quantity: 1358

Code Information:

Lot REXC0931 and REXC0736

Distribution Pattern:

Worldwide Distribution - US nationwide, Belgium, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated