Medical device recalls Moderate risk

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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