Recall Z-1471-2013— Covidien LP

Name: FDA recall Z-1471-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-06

Class II · Terminated

Class II FDA medical device recall by Covidien LP, initiated 2013-05-06, terminated 2014-08-12. It names one FDA 510(k) clearance: K112349. Product: Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.. Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity.

Recalling firm: Covidien LP
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Terminated: 2014-08-12
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K112349 — VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCARCovidien, Formerly US Surgical A Divison of Tyco H·cleared 2011-09-01

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

Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Reason for recall

Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

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