Class 2 Device Recall Recovery Cone Removal System

• Date Initiated by Firm: May 09, 2008
• Date Posted: September 04, 2008
• Recall Status: Terminated on December 10, 2009
• Recall Number: Z-1855-2008
• Recall Event ID: 48125
• Product Classification: Snare, Surgical - Product Code GAE
• Product: Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system.
• Code Information: All lots with expiry dates between May 2008 and February 2011. Serial Numbers: GFRL3426 GFRL3425 GFRL3438 GFRL3439 GFRL3443 GFRL3445 GFRL3448 GFRL3424 GFRL3436 GFRL3437 GFSA0555 GFSA0027 GFSA0556 GFSA0557 GFSA0560 GFSA0610 GFSA0611 GFSA0612 GFSA0613 GFSA0614 GFSA0615 GFSA0644
• FEI Number: 2020394
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St; Tempe AZ 85281-2438
• For Additional Information Contact: Imtiaz Shamji; 480-303-2515
• Manufacturer Reason for Recall: This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body.
• FDA Determined Cause: Device Design
• Action: On May 9, 2008, BARD began distribution of an Urgent Recall Notice with fax-back attachment to all customers in the United States via overnight carrier (FedEx). The Notice informed customers of the problem and the risks associated with the use of this product. The letter instructed their customers to check all inventory locations for the recalled product, remove and return affected product to BPV. The letter also asked their customers to share this information regarding the recall with physicians that perform procedures with the affected product at their facility. Once the product affected by the recall has been removed from their inventory, the customers were asked to contact the BPV Recall Coordinator at 1-800-321-4254 X 2727 to obtain a Return Authorization Number to facilitate replacement of the returned devices. A mailing label was enclosed to return the recalled product.
• Quantity in Commerce: 999
• Distribution: Nationwide
• 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.