Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites afte
FDA device recall Z-1657-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Reason for recall
- Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MGB
- Quantity affected
- 240 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-05-06
- Date posted
- 2009-07-06
- Date terminated
- 2011-12-21
- Location
- Temecula, CA
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