Recall Z-0707-03 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers. Product is packed in a Tyvek pouch and further packed into a shelf carton. Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB,
| Date | Apr 2, 2003 (initiated Feb 3, 2003) |
| Status | Terminated |
| Reason | The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances. |
| Root cause | Other |
| Action | The firm sent via Federal Express Overnight delivery, a notification letter entitled 'IMPORTANT PRODUCT INFORMATION ALERT' dated 2/3/2003 to all user hosptial accounts. The letter warns them of the possibility of partial deployment and how to avoid it. There is no request to stop using or to return the product. The firm considers the action a 'Safety Alert'. |
| Quantity | 32000 |
| Distribution | Product was distributed to 1141 user/medical facilities nationwide. |
| FDA record | Open on fda.gov |