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NOVADAQ TECHNOLOGIES INC. recalls NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq
Recalled October 4, 2017 · FDA recall Z-3234-2017 · 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
6 drapes
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 Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. 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 →