FDA-Device2016-01-06Class II
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Aesculap, Inc.
Hazard
AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier
Sold states
US Distribution to state of: NY.
Affected count
41
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0566-2016Don't want to check this manually?
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