Date Initiated by Firm | December 06, 2013 |
Date Posted | January 23, 2014 |
Recall Status1 |
Terminated 3 on August 05, 2014 |
Recall Number | Z-0814-2014 |
Recall Event ID |
66991 |
Product Classification |
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
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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. |
Code Information |
Lot REXC0931 and REXC0736 |
Recalling Firm/ Manufacturer |
Bard Access Systems 605 North 5600 West Salt Lake City UT 84116-3738
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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 | 1358 |
Distribution | Worldwide Distribution - US nationwide, Belgium, and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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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