Novadaq LUNA Chest Recalled for Sterile Labeling Error
Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.
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 recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Novadaq Technologies, Inc. is recalling 828 units of the LUNA Chest, Model No. LU4006. The recall is due to a labeling error where non-sterile LUNA drapes were inadvertently marked 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. Specific kit and drape lot numbers are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected LUNA Chest units and contact Novadaq Technologies for instructions on how to return or dispose of the product. This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- LUNA Chest, Model No. LU4006
- Manufacturer
- Novadaq Technologies, Inc.
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 828
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 (12)
- Kit Lot Numbers: 13116
- 14012
- 14017
- 14056
- 14074
- 14103
- 14107 Drape Lot Numbers: D132172
- D132602
- D162692
- D132712
- D141002
- D130282
Distribution
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 →Related recalls
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