Recall Z-1855-2008 ยท GAE Snare, Surgical
Bard Peripheral Vascular Inc
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.
| Date | Sep 4, 2008 (initiated May 9, 2008) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 999 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.