Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0109-2019 — Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

U.S. FDA — Device Enforcement · Taiwan · 2018-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0109-2019
Date of alert
2018-08-09
Country / jurisdiction
Taiwan
Risk level
Class II
Risk type
recall
Brand
Besmed Health Business Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
340300000
Reported risk: Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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