Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula 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 Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product…

Recall number

Z-0074-2017

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 Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008