Medical device recalls Moderate risk

Besmed Health Business Corporation recalls Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

Recall date
August 9, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0109-2019
FDA classification
Class II
Brand / firm
Besmed Health Business Corporation
Sold / distributed
US Nationwide, and country of Canada.

Why it was recalled

Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

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