Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
FDA Recall Z-1657-2009 · Posted 2009-07-06
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Recall StatusTerminated
Product CodeMGB
Date Initiated2009-05-06
Date Terminated2011-12-21
Product Quantity240 units
Reason for Recall
Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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