Recall Z-3235-2017— NOVADAQ TECHNOLOGIES INC.

Name: FDA recall Z-3235-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-27

Class II · Terminated

Class II FDA medical device recall by NOVADAQ TECHNOLOGIES INC., initiated 2017-06-27, terminated 2017-12-11. It names one FDA 510(k) clearance: K041501. Product: NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.. Reason: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier..

Recalling firm: NOVADAQ TECHNOLOGIES INC.
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Terminated: 2017-12-11
Firm location: Burnaby, N/A, Canada

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

NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

Reason for recall

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

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