Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3235-2017 — 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, BC,

U.S. FDA — Device Enforcement · Canada · 2017-06-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3235-2017
Date of alert: 2017-06-27
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: NOVADAQ TECHNOLOGIES INC.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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