Recall Z-1657-2009 ยท MGB Device, Hemostasis, Vascular
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
| Date | Jul 6, 2009 (initiated May 6, 2009) |
| Status | Terminated |
| Reason | Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure. |
| Root cause | Process design |
| Action | Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular. |
| Quantity | 240 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.