CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Sterile Drape, SK6000 PAQ drape pouch (for use recalled
Novadaq Technologies is recalling Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY, distributed in Florida, Michigan, Virginia. The recall was initiated on 18 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2767-2016
- FDA event ID
- 75006
- Recalling firm
- Novadaq Technologies, Burnaby
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2016
- FDA classified
- 8 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 18 Aug 2016 | Recall initiated by company | |
| 8 Sep 2016 | Classified by FDA | +21 days |
| 14 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
Where it was distributed
US Distribution in states of: FL, MI, and VA.
Questions about this recall
Is Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY recalled?
Yes. Novadaq Technologies recalled Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY on 18 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2767-2016.
Why was it recalled?
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
Which lots are affected?
Lot # 16047 and 16046
Where was it sold?
US Distribution in states of: FL, MI, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novadaq Technologies
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies | Novadaq Technologies | Sterility | Nationwide |
| Device | CLASS II | Novadaq Spy-phi Paq Intended for use recalled by Novadaq Technologies | Novadaq Technologies | Sterility | Nationwide |
| Device | CLASS II | Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies | Novadaq Technologies | Sterility | Nationwide |
| Device | CLASS II | Pinpoint Endoscopic Fluorescence Imaging System recalled | Novadaq Technologies | Sterility | Nationwide |
| Device | CLASS III | Non-sterile drape recalled by Novadaq Technologies | Novadaq Technologies | Labeling Errors | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |