Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport recalled over sterility concerns
- Recall date
- September 7, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Banyan Medical, LLC recalls Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Produc…
- Recall number
- Z-0075-2017
- FDA classification
- Class II
- Brand / firm
- Banyan Medical, LLC
- Sold / distributed
- IN, TN
Why it was recalled
Potential lack of assurance of sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
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