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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Single Lumen LowProfile port, with PreAttached openEnded Silicone 6.6Fr Catheter.

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  Class 2 Device Recall Titanium Single Lumen LowProfile port, with PreAttached openEnded Silicone 6.6Fr Catheter. see related information
Date Initiated by Firm December 06, 2013
Date Posted January 23, 2014
Recall Status1 Terminated 3 on August 05, 2014
Recall Number Z-0815-2014
Recall Event ID 66991
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product 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.
Code Information Lot REXC0467
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact Carlos A. Arriscorreta
801-522-5706
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 200
Distribution Worldwide Distribution - US nationwide, Belgium, and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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