Recall Z-1409-2017— Covidien LLC

Name: FDA recall Z-1409-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-23

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2017-01-23, terminated 2019-08-07. It names one FDA 510(k) clearance: K041501. Product: Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures. Reason: Sterility compromised due to breach in sterile barrier.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2017-01-23
Terminated: 2019-08-07
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd.·cleared 2004-11-30

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

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

Reason for recall

Sterility compromised due to breach in sterile barrier

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