Z-2767-2016Class II

Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY...

Name: Z-2767-2016 Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY...
Creator: Novadaq Technologies Inc.
Published: 2016-08-18
License: https://open.fda.gov/license/

Novadaq Technologies ULC / initiated 2016-08-18 / Terminated / root cause: packaging

FDA source

NOVADAQ TECHNOLOGIES INC. began a recall of 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... on 2016-08-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2767-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Posted: 2016-09-08
Terminated: 2016-12-09
Recalling firm: Novadaq Technologies ULC
Product: 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.
Product code: IZI System, X-Ray, Angiographic
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Novadaq, sent an "URGENT DEVICE CORRECTION: SK6000 PAQ Drape Pouch" letter dated 8/18/2016 to affected consignees. The Firm instructed consignee to cease distribution of affected product; accept the shipping-validated replacement PAQ; complete and sign the enclosed "Acknowledgment of Receipt" form, scan it and email to [email protected]. If you have any questions, contact Director of Regulatory Affairs at 1-905-629-3822 ext 205 or email: [email protected]. .
Quantity in commerce: 20 units
Distribution: US Distribution in states of: FL, MI, and VA.
Product codes and lots: Lot # 16047 and 16046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2767-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2767-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code IZI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)