FDA Recalls Ambu Aura40 Reusable Laryngeal Masks Due to Labeling Error
Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.
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, but the hazard is limited to a labeling error regarding the reusability of the device, which fits the criteria for moderate severity involving minor labeling issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Ambu Aura40 Standard, Reusable Laryngeal Masks (Catalog Number: 340300000) manufactured by Besmed Health Business Corporation. The recall involves 267 units distributed nationwide in the United States and in Canada. The affected products are identified by Lot Numbers MO0612G40021 and MO0605G40014.
The reason for the recall is a labeling discrepancy: the reusable laryngeal masks are packaged in pouches marked "AuraStraight Silicone, Single Use Laryngeal Mask Sterile." This packaging incorrectly identifies the product as single-use rather than reusable.
Healthcare providers and consumers should stop using these specific units and contact Besmed Health Business Corporation for further instructions or a replacement.
The recalled product
- Product
- Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
- Manufacturer
- Besmed Health Business Corporation
- Hazard
- Affected units
- 267
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 Numbers: MO0612G40021 and MO0605G40014
Distribution
Distributed nationwide across the United States.
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