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FDAJune 27, 2017device

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, B...

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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