Agency classClass IIIOur severity:Low FDA (Devices)·Z-0470-2015·Announced 2014-12-03

Novadaq Non-Sterile Drape Recalled for Incorrect Sterile Labeling

Novadaq Technologies is recalling 324 non-sterile LUNA drapes that were inadvertently mislabeled with an additional contents sterile label.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to a labeling error.

Plain-English summary

Novadaq Technologies, Inc. is recalling 324 units of the Non-sterile drape LUNA drape. The recall was initiated because the product was inadvertently mislabeled with an additional contents sterile label.

The affected products were distributed nationwide to facilities in Iowa, Louisiana, Georgia, Maryland, Idaho, Florida, Tennessee, Ohio, Texas, North Carolina, Massachusetts, Kentucky, Kansas, Wisconsin, Indiana, South Carolina, Oregon, Connecticut, California, Washington, Pennsylvania, Oklahoma, and Puerto Rico. The specific kit lot numbers involved are 14082, 14091, 14104, and 14106, while the drape lot numbers are D132712, D133102, D141022, and D130282.

The U.S. Food and Drug Administration has classified this recall as Class III. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected drapes if they match the listed identifiers.

The recalled product

Product: Non-sterile drape
Manufacturer: Novadaq Technologies, Inc.
Category: Medical Device — Surgical Drapes
Hazard: mis-labeling
Affected units: 324

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 (7)

Kit Lot Numbers: 14082
14091
14104
14106 Drape Lot Numbers: D132712
D133102
D141022
D130282

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Novadaq Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Novadaq Technologies, Inc.

See all →

High
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FDA (Devices) · 2017-10-04
High
Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2017-10-04
High
Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-10-04
Moderate
Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect
FDA (Devices) · 2016-09-14
Moderate
Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error
FDA (Devices) · 2016-03-09

Same hazard · mis labeling