Recall Z-0469-2015— Novadaq Technologies, Inc.

Name: FDA recall Z-0469-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class III · Terminated

Class III FDA medical device recall by Novadaq Technologies, Inc., initiated 2014-11-04, terminated 2015-11-06. It names one FDA 510(k) clearance: K071619. Product: LUNA Chest, Model No. LU4006. Reason: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label..

Recalling firm: Novadaq Technologies, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-11-04
Terminated: 2015-11-06
Firm location: Richmond, British Columbia, Canada

510(k) clearances named in this recall

1 on FDA's record

K071619 — SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc.·cleared 2007-11-09

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

LUNA Chest, Model No. LU4006

Reason for recall

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

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