Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503 recalled over sterility concerns
- Recall date
- January 20, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Surgical Innovations Ltd recalls Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use…
- Recall number
- Z-1852-2022
- FDA classification
- Class II
- Brand / firm
- Surgical Innovations Ltd
- Sold / distributed
- US: MA
Why it was recalled
Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
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