Reported Feb 22, 2017 · Terminated
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Abbott Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
- Lot codes and dates
- Part No.Part No.
14679-0150908K150916K151013K151021K151106K1510124151014415101941510214151027415103141511054151110415121041512154151217415122341601264160129416020341602084160211416021641602184160225416022941603034160308416041241
14679-0250831K150903K150911K150921K150924K150929K151002K151008K151016K151026K151029K151103K15111741511204151124415112741512014151204416010641601114160114416011941601224160310416031541603224160329416041941604214160426416042941605114160513416051941605244160615416100341
- Part No.
- Amount recalled
- 170,008 units total (83,029 units in US)
Where it was sold
Why it was recalled
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
This product could cause temporary or reversible health problems — stop using it.
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