—#70857

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.

FDA product code: GAE — Snare, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2008-05-09
Posted by FDA: 2008-09-04
Terminated: 2009-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.