Reported Oct 4, 2017 · Terminated

NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured…

Novadaq Technologies Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NOVADAQ TECHNOLOGIES INC. · 8329 Eastlake Dr Unit 101 · Burnaby, N/A · N/A

Is this the product you have?

  • NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx
  • Manufactured forNovadaq 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
Lot codes and dates
    • Lots #1703291
    • #1704141
    • and #1704101
Amount recalled
3/20-drape boxes

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 11, 2017 · Data as of Sep 19, 5:20 PM UTC

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