The Recall Desk

FDA (Devices) recall action 77901

NOVADAQ TECHNOLOGIES INC. recalled 3 products on 2017-10-04

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-10-04
Critical
0
Units
6

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2017-10-04

    Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes

    Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.

    Product
    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2017-10-04

    Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is intended for equipment coverage, not patient contact.

    Product
    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2017-10-04

    Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is used to cover surgical equipment, not patients.

    Product
    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), 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 th
    Category
    Distribution
    7 states