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

Recall Z-3234-2017 — 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

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3234-2017
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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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