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NOVADAQ TECHNOLOGIES INC. recalls NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (P
Recalled October 4, 2017 · FDA recall Z-3235-2017 · NOVADAQ TECHNOLOGIES
Hazard
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. · FDA Class II
Units
16/6-drape kits
Sold at
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Description
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
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.
Manufacturer(s)
NOVADAQ TECHNOLOGIES INC.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →