FDAJune 27, 2017device

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 sur...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

novadaq technologiesnovadaq

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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