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 T…

Recall date

June 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3234-2017

FDA classification

Class II

Brand / firm

NOVADAQ TECHNOLOGIES INC.

Sold / distributed

Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.