Sterile Drape — Class II medical device recall Z-2767-2016
Terminated recall by NOVADAQ TECHNOLOGIES INC., reported 2016-09-14, distributed in FL, MI, VA. Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in s
| Recall number | Z-2767-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOVADAQ TECHNOLOGIES INC., Burnaby, Canada |
| Recall initiated | 2016-08-18 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2016-12-09 |
| Distributed | FL, MI, VA |
| Quantity | 20 units |
| Lot numbers | 16046, 16047 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2767-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.