FDA-Device2017-02-22Class II
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Abbott Vascular
Hazard
Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.
Sold states
US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
Affected count
170,008 units total (83,029 units in US)
Manufactured in
26531 Ynez Rd, N/A, Temecula, CA, United States
Products
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2017Don't want to check this manually?
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