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.
What this means for you
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
- 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
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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