FDA-Device2017-10-04Class II
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.
NOVADAQ TECHNOLOGIES INC.
Hazard
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Sold states
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Affected count
6 drapes
Manufactured in
8329 Eastlake Dr Unit 101, N/A, Burnaby, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3234-2017Don't want to check this manually?
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