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Terminated

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.

FDA Recall Z-2767-2016 · Posted None

Recalling FirmNOVADAQ TECHNOLOGIES INC.
Recall StatusTerminated
Product CodeIZI
Date Initiated2016-08-18
Date Terminated2016-12-09
Product Quantity20 units

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.

Firm 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]. .

Root Cause

Packaging

Distribution Pattern

US Distribution in states of: FL, MI, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071619SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc. · 2007-11-09K072222SPY FLUORESCENT IMAGING SYSTEMNovadaq Technologies, Inc. · 2007-09-07K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000Novadaq Technologies, Inc. · 2007-05-10K063345SPY IMAGING SYSTEMNovadaq Technologies, Inc. · 2007-01-12K060867SPY INTRAOPERATIVE IMAGING SYSTEMNovadaq Technologies, Inc. · 2006-05-03K042961SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000Novadaq Technologies, Inc. · 2005-01-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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