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.
FDA Recall Z-0815-2014 · Posted 2014-01-23
Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeFOZ
Date Initiated2013-12-06
Date Terminated2014-08-05
Product Quantity200
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.
Firm Action
BARD sent an Urgent Product Recall letter dated October 2013 to affected customers via certified letter. The letter identified the affected product, problem and actions to be taken. Customers were asked to check all inventory locations, remove and return any unused affected prodcut to Bard Access Systems through return goods authorization number RAP80498 for a credit or replacement, and to complete the Reply Form and Inventory Reconcilation Form. For questions contact BAS Customer Service at 1-800-290-1689.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US nationwide, Belgium, and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.