Recall Z-0075-2017— Banyan Medical, LLC

Name: FDA recall Z-0075-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-07

Class II · Terminated

Class II FDA medical device recall by Banyan Medical, LLC, initiated 2016-09-07, terminated 2021-03-09. It names one FDA 510(k) clearance: K133375. Product: Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009. Reason: Potential lack of assurance of sterility.

Recalling firm: Banyan Medical, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Terminated: 2021-03-09
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K133375 — BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCARBanyan Medical, LLC·cleared 2014-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009

Reason for recall

Potential lack of assurance of sterility

Data sourced from openFDA. This site is unofficial and independent of the FDA.