Recall Z-0762-04 ยท MGB Device, Hemostasis, Vascular
Datascope Collagen Products Division
VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery
| Date | Jul 20, 2004 (initiated Jul 28, 2003) |
| Status | Terminated |
| Reason | Kits are missing the temporary arteriotomy locator (TAL) from the blister package. |
| Root cause | Other |
| Action | 'Urgent Customer Advisory' Letter dated July 28, 2003. |
| Quantity | 1485 kits |
| Distribution | The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.