Recall Z-0889-2017— Medtronic

Name: FDA recall Z-0889-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-04

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2016-10-04, terminated 2018-08-08. It names one FDA 510(k) clearance: K062779. Product: Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens. Reason: Product sterility is compromised due to breach of the sterile barrier.

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2016-10-04
Terminated: 2018-08-08
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K062779 — DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)New Wave Surgical Corporation·cleared 2006-10-05

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

Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

Reason for recall

Product sterility is compromised due to breach of the sterile barrier

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