Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect
Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (pinhole) was identified during validation testing with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Novadaq Technologies Inc. is recalling 20 units of the SK6000 PAQ sterile drape pouch, which is used with the SPY Fluorescent System for visual assessment of blood flow during cardiovascular surgery. The recall was initiated after a pinhole through the drape pouch film material was identified in some units during shipping validation testing.
The affected units are from Lot # 16047 and 16046. These products were distributed in the United States to the states of Florida, Michigan, and Virginia. The SPY Fluorescent Imaging System is intended for intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass surgery.
Users of the SK6000 PAQ drape pouches should stop using the affected lots and contact Novadaq for further instructions.
The recalled product
- 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 su
- Manufacturer
- NOVADAQ TECHNOLOGIES INC.
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 16047 and 16046
Distribution
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