Recall Z-0814-2014— Bard Access Systems

Class II FDA medical device recall by Bard Access Systems, initiated 2013-12-06, terminated 2014-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm

Bard Access Systems

Classification

Class II

Status

Terminated

Initiated

2013-12-06

Terminated

2014-08-05

Firm location

Salt Lake City, UT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.