Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the

FDA device recall Z-1854-2008 · posted 2008-09-04 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GAE

Quantity affected

11,679

Distribution

Nationwide

Date initiated

2008-05-09

Date posted

2008-09-04

Date terminated

2009-12-10

Location

Tempe, AZ