FDA-Device2023-06-14Class II
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Cardinal Health 200, LLC
Hazard
Inadvertently released for distibution without sterility assurance.
Sold states
Distribution in the US to Georgia
Affected count
5 units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2023Don't want to check this manually?
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