Summit Medical, LLC recalls Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Recall date
- January 13, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1171-2023
- FDA classification
- Class II
- Brand / firm
- Summit Medical, LLC
- Sold / distributed
- 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.
Why it was recalled
Sterile product pouches were not sealed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
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