FDA-Device2023-03-08Class II
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Summit Medical, LLC
Hazard
Sterile product pouches were not sealed.
Sold states
US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.
Affected count
30 devices
Manufactured in
815 Vikings Pkwy Ste 100, N/A, Eagan, MN, United States
Products
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1171-2023Don't want to check this manually?
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